EP2512547B1 - Balancing device, external medical functional device, treatment device - Google Patents

Balancing device, external medical functional device, treatment device Download PDF

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Publication number
EP2512547B1
EP2512547B1 EP20100803227 EP10803227A EP2512547B1 EP 2512547 B1 EP2512547 B1 EP 2512547B1 EP 20100803227 EP20100803227 EP 20100803227 EP 10803227 A EP10803227 A EP 10803227A EP 2512547 B1 EP2512547 B1 EP 2512547B1
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EP
European Patent Office
Prior art keywords
balancing
pressure
conveying means
chamber
balancing unit
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP20100803227
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German (de)
French (fr)
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EP2512547A1 (en
Inventor
Arne Peters
Alexander Heide
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Medical Care Deutschland GmbH
Original Assignee
Fresenius Medical Care Deutschland GmbH
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Publication date
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Priority to PL10803227T priority Critical patent/PL2512547T3/en
Publication of EP2512547A1 publication Critical patent/EP2512547A1/en
Application granted granted Critical
Publication of EP2512547B1 publication Critical patent/EP2512547B1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1621Constructional aspects thereof
    • A61M1/1635Constructional aspects thereof with volume chamber balancing devices between used and fresh dialysis fluid
    • A61M1/1639Constructional aspects thereof with volume chamber balancing devices between used and fresh dialysis fluid linked by membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3622Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/104Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
    • A61M60/109Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems
    • A61M60/113Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems in other functional devices, e.g. dialysers or heart-lung machines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20Type thereof
    • A61M60/205Non-positive displacement blood pumps
    • A61M60/216Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/226Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly radial components
    • A61M60/232Centrifugal pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20Type thereof
    • A61M60/247Positive displacement blood pumps
    • A61M60/253Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/268Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/30Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/36Medical purposes thereof other than the enhancement of the cardiac output for specific blood treatment; for specific therapy
    • A61M60/37Haemodialysis, haemofiltration or diafiltration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40Details relating to driving
    • A61M60/403Details relating to driving for non-positive displacement blood pumps
    • A61M60/422Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50Details relating to control
    • A61M60/508Electronic control means, e.g. for feedback regulation
    • A61M60/538Regulation using real-time blood pump operational parameter data, e.g. motor current
    • A61M60/554Regulation using real-time blood pump operational parameter data, e.g. motor current of blood pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50Details relating to control
    • A61M60/585User interfaces
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/802Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/818Bearings
    • A61M60/82Magnetic bearings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/845Constructional details other than related to driving of extracorporeal blood pumps
    • A61M60/847Constructional details other than related to driving of extracorporeal blood pumps arranged in a cassette
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/845Constructional details other than related to driving of extracorporeal blood pumps
    • A61M60/849Disposable parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/15Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/15Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
    • A61M1/156Constructional details of the cassette, e.g. specific details on material or shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3622Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36226Constructional details of cassettes, e.g. specific details on material or shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit

Definitions

  • the present invention relates to a balancing device according to claim 1. It further relates to an external medical functional device according to claim 7 and a treatment device according to claim 10.
  • Balancing devices are known for balancing volume and / or volume flows of medical fluids such as blood or fluids used during the blood treatment.
  • the US 4,997,570 A discloses a balancing device with a pump.
  • the EP 0 623 357 A1 describes a dialyzer with pumps.
  • the US 3,709,222 A describes a dialyzer with rotating peristaltic pumps.
  • the EP 0 900 572 A1 discloses a centrifugal pump for conveying a fluid.
  • An object of the present invention is to propose a further balancing device.
  • a balancing device for balancing medical fluids in particular for balancing dialysate, with the features of claim 1.
  • the balancing device has at least one balancing chamber and at least one conveying device for filling the balancing chamber.
  • the term "accounting” is understood, in one embodiment, to be a comparison of amounts and / or volumes of medical fluids that are delivered to or removed from a patient or treatment device for treating the patient.
  • patient refers to a human or an animal, whether ill or healthy.
  • a “balancing chamber” in the sense of the present invention refers to a device which is provided to receive the medical fluids to be balanced - or partial quantities thereof - in an inner or inner volume.
  • the balancing chamber in one embodiment according to the invention is a chamber which is subdivided into at least two balancing chamber halves or sections by at least one dividing wall or membrane, which can be designed to be displaceable or flexible. At least one of the balancing chamber halves or sections may be provided to receive supplied or fresh medical fluids. At least one more balancing chamber half or another
  • Balancing section may be provided to receive discharged medical fluids.
  • the balancing means may comprise more than one balancing chamber, i. e.g. two, three, four or more balancing chambers.
  • two balancing chambers can be advantageously used to ensure a continuous flow of medical fluids during balancing.
  • the balancing chambers may or may not be in fluid communication with each other.
  • the balancing chambers can be filled and / or emptied together or separately.
  • Each balancing chamber may include (one or more) supply lines for supplied or fresh medical fluids and (one or more) outlet lines for drained spent medical fluids connected to an outlet.
  • shut-off valves can be arranged in the supply and / or in the discharge lines.
  • shut-off valves examples include actuators that are extendable and / or retractable from a portion of a machine, such as a treatment device. By means of these actuators it may be possible to prevent or release a fluid flow within a fluid system of the medical fluids.
  • actuators include those filed in the application filed with the German Patent and Trademark Office by the Applicant of the present application on June 10, 2009 10 2009 024 468.9 entitled "External functional device,
  • balancing chambers according to an embodiment of the balancing device of the present invention and their respective function are in the aforementioned EP 0 867 195 B1 the assignee of the present application.
  • the conveyor may be part of a fluid system in which the medical fluid is present.
  • the conveyor may e.g. be installed or switched to convey the medical fluid in the fluid system.
  • the conveyor may be flowed through in its use of the medical fluid to be balanced.
  • the fluid system may include conduits, hoses, tubing, channels, chambers, protrusions, devices or spaces or areas for storing or holding or retaining fluids, and control devices for controlling or controlling a flow rate of the fluids and the like.
  • the fluid system is provided in certain embodiments for a dialysis fluid.
  • the fluid system in certain embodiments, is for blood in extracorporeal blood circulation or other fluids intended.
  • the other fluids include citrate and / or calcium solution, water or hydraulic fluid.
  • filling pressure The pressure prevailing in the balancing chamber during filling is referred to below as filling pressure. He can be changeable. He can be rising. He can be different in size at different moments.
  • a maximum filling pressure of the balancing device according to the invention can be fixed over a set speed of the conveyor.
  • the maximum inflation pressure may be determined by the characteristic of the conveyor, e.g. a pump characteristic, be specified.
  • the flow and / or delivery pressure of the conveyor is measured by suitable means.
  • Corresponding means can be configured and provided for this purpose.
  • the maximum filling pressure for filling the balancing chamber of the balancing device can be predetermined.
  • the maximum filling pressure can be set or adjusted by changing the operating parameters of the conveying device (for example by influencing the rotational speed of a pump).
  • the operating parameters of the conveying device eg by influencing the rotational speed of a pump
  • the maximum inflation pressure may, in one embodiment, after it has been reached by the conveyor for a time kept constant or, in another embodiment, fall off. This can be done depending on the preload.
  • the maximum filling pressure can be achieved, for example, when the balancing chamber is substantially or completely filled or filled with the medical fluid (s) to be balanced.
  • the maximum inflation pressure may also be reached when a balancing chamber half or balancing chamber section has been substantially or completely filled by operating the conveyor.
  • the "pressure-limited conveying device” is a conveying device which, after reaching a maximum pressure or filling pressure, does not build up any higher pressure in the interior of the balancing chamber.
  • the "pressure-limited conveyor” is in another embodiment of the balancing device according to the invention, a pump, the impeller is flowed over upon reaching the maximum filling pressure of the pumped fluid.
  • the "pressure-limited conveyor” is in a further embodiment of the balancing device according to the invention a conveyor, which can be operated in at least one operating state as a constant pressure source or as a pressure source with constant or approximately constant pressure.
  • the "pressure-limited conveying device” is a conveying device which comprises or consists of at least one pump, wherein the pump has no overflow valves and / or bypass lines or is functionally connected to such.
  • the "pressure-limited conveyor” is in a further embodiment of the balancing device according to the invention, a conveyor which is not connected to a control device for the purpose - and / or provided for this purpose and corresponding configured control device -, a pressure relief of the conveyor depending on a during the filling of the balancing chamber to make the prevailing in this filling pressure.
  • the "pressure-limited conveyor” is in the balancing device according to the invention, a pump which due to their design no pressure above a predetermined pressure addition - here the filling pressure - builds. It is here in at least one embodiment of the balancing device according to the invention by any other elements, in particular no control, circuit, valves, bypass pressure relief valves, pressure measuring devices and the like, each directly or indirectly supported.
  • the "pressure-limited conveying device” is a conveying device, in the use of which the balancing chamber filled by it can be assumed to be a volume-stable chamber after reaching a maximum pressure or filling pressure set on the machine side.
  • the balancing device has, in an embodiment according to the invention, several conveying devices.
  • the balancing means does not comprise overflow valves, bypass lines, controls, circuits, valves, bypass overpressure valves, pressure measuring devices and the like which are suitable and intended or configured for limiting the delivery pressure of the delivery device.
  • the balancing device has in an embodiment according to the invention no roller pump or gear pump with bypass valve and / or pressure control.
  • the balancing device according to the invention has a plurality of conveying devices, they can be configured identically or differently in one embodiment.
  • this has a plurality of conveyors connected in series. In this way, it may be advantageous to specifically relieve the balancing chamber.
  • the individual conveying devices are arranged in an embodiment according to the invention of the balancing device in order to run or be operated in the same conveying direction or to convey in the same direction.
  • the conveyors run in different directions or promote in opposite directions.
  • At least two conveyors run in the same direction or convey in the same direction.
  • a centrifugal pump or a centrifugal pump can advantageously provide a high volume flow at low pressures and / or a low flow rate at high pressures.
  • the centrifugal pump in an embodiment according to the invention is an axial pump with the advantages known to the person skilled in the art in connection with axial pumps.
  • the centrifugal pump is a radial pump or a diagonal pump with the advantages known to the person skilled in the art in connection with radial pumps or diagonal pumps.
  • the maximum pressure of the centrifugal pump - and thus the maximum filling pressure - can be determined by the speed, e.g. be set by means of speed limitation, so that the maximum pressure load on the entire system can be advantageous (very) exactly defined.
  • the centrifugal pump may have the characteristic that, starting from a certain fluid pressure, e.g. when the balancing chamber is completely filled, an overflow of the impeller or the rotation section occurs. This overflow can result in a pressure limitation in the conveyed fluid, such that the centrifugal pump operates under pressure limitation in the sense of the present invention.
  • centrifugal pump in one embodiment advantageously requires no support by other components such as control, regulation, valves, etc.
  • a pressure source is understood according to the invention to mean any fluid delivery device whose output fluid pressure is constant or substantially constant.
  • the conveying device has at least one rotating or rotating section or one rotating section. This is mechanically stored in one embodiment of the invention, in another it is magnetically supported.
  • the rotation section may be exclusively or additionally magnetically mounted.
  • the rotation section may be arranged in an interior of the conveyor.
  • the rotating section may be completely immersed in use by the medical fluids flowing through the conveyor during use.
  • the rotating section is an impeller or a rotor in one embodiment.
  • the conveying device has at least one rotary section, which is provided and configured to be drivable or operated by means of an external drive magnetically or by means of an electric field.
  • the external drive of the rotary section is configured to be driven mechanically, eg via detachable, fluid-tight couplings.
  • external drive refers to a drive for the rotating section, which may be part of the balancing device but need not be part.
  • the external drive can be arranged on a device which cooperates with a balancing device according to the invention, such as a treatment device.
  • the external drive may be part of the device.
  • the magnetic driving force or effect can be achieved by means of one or more magnets. It can be achieved with the help of current-carrying conductors. For example, current-carrying coils can be used.
  • the conveying device is a magnetically mounted centrifugal pump, as used, for example, in US Pat EP 0 900 572 A1 is disclosed.
  • Such a magnetically mounted centrifugal pump can offer the advantage that no mechanical and / or electrical interface to the machine is required and / or no fluids have to be transferred from the machine or the treatment device to the pump ,
  • the medical fluid is selected from dialysis fluid, blood, substituate fluid, medicaments, Drug preparations and mixtures or combinations thereof.
  • balancing on the blood side during dialysis is envisaged according to the invention.
  • Other fluids which may be required to be included in the blood treatment of a patient of interest and / or include solutions or diseased metabolic products of the subject, such as urinary substances, and the like.
  • At least one first conveyor is provided to convey in a first direction.
  • At least a second conveyor to promote in a second, the first opposite direction.
  • the object of the present invention is further achieved by an external medical functional device according to claim 7. All achievable with the balancing device according to the invention advantages can be achieved in certain embodiments undiminished even with the external medical functional device according to the invention, which has at least one balancing device according to the invention.
  • the external medical device is an external fluid circuit with dialysate and extracorporeal blood circulation, or is designed as a blood or dialysate cassette or combined blood / dialysate cassette.
  • the external medical functional device may e.g. a blood or dialysate cassette or a combined blood / dialysate cassette for dialysis.
  • the external medical device is a disposable, disposable, or disposable product.
  • the external medical device is a disposable cassette.
  • the disposable cassette can be a hard part. It can be made of a plastic material.
  • the disposable cassette may be made by an injection molding process.
  • the object of the present invention is further achieved by a treatment device according to claim 10. All achievable with the balancing device according to the invention advantages can be achieved undiminished in certain embodiments, even with the treatment device according to the invention.
  • the treatment device according to the invention is suitable for the treatment of medical fluids. It is designed to operate at least one balancing device according to the invention.
  • the treatment device may have a control or regulating device.
  • the control or regulating device may be a microprocessor or have such a microprocessor.
  • the treatment device has a device which is provided and configured to drive the delivery device of the balancing device via a magnetic drive interface.
  • the device may be, for example, a magnet or a magnetically acting system and / or a current-carrying conductor, such as one or more current-carrying coils, or have these.
  • the treatment device may be functionally connected to a balancing device according to the invention and / or to an external medical functional device according to the invention.
  • the treatment device according to the invention comprises in an embodiment according to the invention at least one balancing device according to the invention.
  • the treatment device according to the invention is firmly connected in one embodiment according to the invention with the balancing device according to the invention.
  • a repeated use of the firmly connected balancing device according to the invention is provided in an embodiment according to the invention.
  • the treatment device according to the invention is a hemodialysis device in one embodiment according to the invention.
  • the treatment device further includes, in certain embodiments, further means or is provided for coupling therewith.
  • additional means or is provided for coupling therewith include, for example, an extracorporeal blood circulation, control or regulating devices for triggering the execution of a medical treatment, devices for monitoring and / or displaying a balance of the medical fluids used and / or circulated during a medical treatment, devices for displaying or displaying states, and / or parameters of the medical treatment or the balance, such as screens and the like, means for operating or driving one or more components of the treatment device, such as keyboards and the like, for example to initiate medical treatment, and the like.
  • the treatment device is a blood treatment device.
  • Examples of blood treatment methods include dialysis methods such as hemodialysis, especially by ultrafiltration, hemodiafiltration, peritoneal dialysis, automatic peritoneal dialysis, and the like.
  • the blood treatment device may be designed to carry out these methods.
  • the balancing device according to the invention can advantageously be used to determine the volume the dialysis fluid, which is passed into the peritoneal region of the patient and / or from there out of the patient, are used.
  • both balancing chamber halves of a two-part balancing chamber of the balancing device can be filled alternately with fresh dialysis fluid (when the dialysis fluid enters the abdominal cavity of the patient) and / or with used dialysis fluid (when removing the dialysis fluid from the patient's abdominal cavity).
  • the volumes and / or quantities of the medical fluids, eg the dialysis fluid, which are of interest in a balancing can be determined, for example, via the number of fillings of the balancing chamber.
  • a method comprises balancing at least one medical fluid using at least one balancing device according to the invention or at least one external medical functional device according to the invention or at least one treatment device according to the invention.
  • One method comprises filling a balancing chamber by means of at least one conveying device and operating the conveying device in at least one operating state as a constant pressure source.
  • a certain speed of the conveyor can be set, in which a fixed or fixed or predetermined pressure difference over the conveyor can be set.
  • the present invention proposes a balancing device in which the delivery device is operated as a constant pressure source after filling the balancing chamber (s).
  • the constant pressure source can advantageously help to ensure a maximum filling pressure within the balancing chamber.
  • the structural requirements of the balancing chamber can thus be lower.
  • a balancing accuracy may depend primarily on the pressure fluctuations between two filling operations, which can be explained by the fact that the switching operation for terminating a filling process is subject to slight fluctuations, and that the increase of the filling pressure or the chamber internal pressure considerably increases towards the end of the filling.
  • the medical fluids introduced into the balancing chamber by means of the conveying device can displace the fluids present in the balancing chamber to the same extent or at the same speed or rate, it may be advantageously possible to produce a constant or uniform volume and / or volumetric flow of the fluids to be balanced to reach.
  • the pressure-limited delivery device can predetermine an advantageously precisely controllable balancing chamber pressure (also dynamically controllable) during the balancing of the medical fluids.
  • An adverse increase in pressure and / or pressure fluctuations of the balancing chamber can be advantageously avoided.
  • An undesirable volume expansion or change of the balancing chamber can be advantageously prevented.
  • This may also, for example, beneficially contribute to reducing the volume of fluid that can be delivered to a patient during a treatment, e.g. an ultrafiltration during a dialysis treatment, is withdrawn over the dialysis filter membrane, to determine precisely and / or set to the desired rate by the treating physician.
  • a treatment e.g. an ultrafiltration during a dialysis treatment
  • the safety and possibly also the compatibility of a blood treatment can be further improved so advantageous.
  • the balancing device in at least one embodiment, can be improved Balancing accuracy advantageous for improved and / or safer treatment - eg by a more appropriate setting an ultrafiltration rate - lead.
  • the balancing chamber of the balancing device according to the invention can be advantageously used as a pressure-limited volumetric balancing chamber with sufficient strength.
  • a support of walls of the balance chamber to fixed structures of the treatment device is not required.
  • the application possibilities of the balancing device have become broader without losing their functional accuracy.
  • the conveyor in the balancing device according to the invention can advantageously manage without the use of sensors and / or overflow valves and / or bypass overpressure valves, in particular for the purpose of limiting the pressure in an interior of the balancing chamber, and the like.
  • the conveyor device can be designed simpler.
  • the construction of the conveyor can be advantageously simplified.
  • mechanical components such as bearings and the like, and in this way advantageously ensure low wear of the components and / or low particle abrasion.
  • heating of the conveyor device or of the balancing device can advantageously also be avoided or reduced.
  • the conveying device of the balancing device according to the invention can advantageously have a low tendency to cavitate.
  • Another advantage may be a low noise during use of the balancing device according to the invention.
  • the pressure of the conveyor does not increase even with a sustained flow after completion of the filling of the balancing chamber, can be bypassed advantageous to have to shut down the conveyor at full, ie substantially or completely filled, balancing chamber.
  • a fluid flowing through the centrifugal pump can overflow a rotary section of the centrifugal pump. In this way, a good flushability (and Um réelleles) of the conveyor can be ensured with a directed flow in the space traversed by the centrifugal pump.
  • the magnetic drive interface for operating the conveyor or a rotation section thereof can advantageously provide a non-contact and / or seal-free drive of the conveyor. In this way, it may be advantageously possible to dispense with open interfaces between the balancing device and the treatment device.
  • the balancing device according to the invention can advantageously be described as disposable, i. used as disposables for single use. Since the conveyor can be provided as an integral part of the disposable, it can be discarded together with the disposable, whereby the safety and hygiene of medical treatment can be advantageously further improved.
  • centrifugal pumps in certain embodiments, has the advantage of inherently limiting the pressure upon occlusion downstream of the pump, as compared to the pressure controlled tubular roller, gear or peristaltic pumps.
  • the pressure built up there can be easily adjusted by the speed.
  • a pressure-controlled hose roller pump requires at least one pressure sensor with control circuit; a hose roller pump with
  • Overpressure bypass valve must be calibrated to exactly the allowed pressure.
  • the balancing device according to the invention is therefore less complicated in certain embodiments.
  • the balancing device is described below by way of example as part of a blood treatment device for dialysis. It is intended to balance the dialysis fluid supplied to and discharged from a patient. In principle, however, it can also be provided to balance the blood of the patient.
  • Fig. 1 shows a balancing device 100 according to the present invention with a balancing chamber.
  • the balancing chamber 1 is divided into a first balancing chamber half 3a and a second balancing chamber half 3b.
  • the balancing chamber does not have to be essentially two or three be divided completely equal balancing chamber halves.
  • the first balancing chamber half 3a is separated from the second balancing chamber half 3b by a fluid-impermeable membrane 5.
  • the first balancing chamber half 3a is filled with a stream 7a of a dialysis fluid via a hose 9a.
  • a valve 11a is located in the open position by means of an actuating mechanism 13a.
  • the conveyor may be a centrifugal pump. As in Fig. 1 is shown, the first chamber half 3a is filled by means of a centrifugal pump 15a.
  • the valve 11a can be designed as a hose clamp (or generally as a squeezing mechanism). Such a hose clamp can be opened and closed by an electrically controlled actuator. This has the advantage that the medical fluid has essentially only contact with the hose 9a, but not with parts of the valve 11a or the adjusting mechanism 13a. This can advantageously contribute to reducing the risk of contamination for the medical fluids.
  • a second stream 7b of the dialysis fluid is discharged through a hose 9b from the second balancing chamber half 3b.
  • a valve 11b is also in the open position, mediated by an adjusting mechanism 13b.
  • the second balancing chamber half 3b can be emptied.
  • the discharge or removal of dialysis fluid from the second balancing chamber half 3b can be carried out simultaneously with the introduction or introduction of dialysis fluid into the first balancing chamber half 3a.
  • Valves 11c and 11d are as in FIG Fig. 1 shown, in each case closed by means of the corresponding adjusting mechanisms 13c and 13d. No fluid is delivered in hoses 9c and 9d.
  • Fig. 2 shows a diagram with a pressure curve 17 during a balancing chamber filling as a function of time.
  • a final pressure 18, which corresponds to the end point of the pressure curve at balance chamber filling 17 and thus the maximum filling pressure, may depend on the pressure which the centrifugal pump 15a applies. This pressure can in turn depend on several parameters of the centrifugal pump Depending on the construction principle of the centrifugal pump (radial, axial, Diagonal pump, impeller shape, diameter of the impeller, etc.) and / or the set speed of the centrifugal pump 15a and thus the set operating point. Further, the discharge pressure may depend on the preload of the centrifugal pump 15a, that is, the pressure applied to a dialyzate inlet of the centrifugal pump 15a.
  • Fig. 3 shows a diagram with a pressure difference .DELTA.P between the Pumpenaus- and the pump inlet of a centrifugal pump 15a (ordinate) as a function of the volume flow Q of medical fluids (abscissa).
  • the pressure difference .DELTA.P is independent of the volume flow Q.
  • the height or the extent of the pressure difference .DELTA.P depends inter alia on the set speed of a centrifugal pump.
  • FIG. 1 shows the characteristic curve 21 of a centrifugal pump. It can be seen that a good approximation of the pressure curve to the ideal characteristic curve can be achieved by means of the centrifugal pump 15a.
  • Fig. 3 also shows that the centrifugal pump 15a can be understood as a pressure-limited conveying device in the sense of the present invention: the pump outlet pressure does not increase any further after reaching a certain pressure despite increasing volume flow.
  • Fig. 4 shows the balancing device 100 of Fig. 1 during a second work cycle.
  • the second work cycle can correspond to the first work cycle Fig. 1 follow.
  • a stream 7c of dialysis fluid is conveyed in the second power stroke by a centrifugal pump 15c through the hose 9c into the second chamber half 3b. At the same time, a stream 7d of dialysis fluid from the first chamber half 3a is emptied.
  • Fig. 5 shows the balancing device 100 of Fig. 1 with two additional, the balancing chamber 1 downstream centrifugal pumps 15b and 15d.
  • centrifugal pumps 15a-d promote all in the same conveying direction, as with the left (based on the representation of Fig. 5 ) pointing pump arrow heads is indicated.
  • the emptying of the two chamber halves 3a and 3b can be supported.
  • This may be advantageous, for example, to achieve maximum pressure (see Fig. 2 the end point 18 of the curve of the pressure curve) in the balancing chamber 1 to reduce or keep low.
  • Low pressures in the balancing chamber 1 can in turn advantageously contribute to simplify the construction (such as a lower rigidity, lower material thicknesses, etc.) of the balancing device 100 as stated above.
  • the latter can be advantageous in particular in one embodiment of the balancing device 100 as part of a disposable.
  • Fig. 6 shows the balancing device 100 with the balancing chamber 1 similar to in Fig. 5 with the difference that the centrifugal pump 15b is provided and configured to also run in a different direction or in opposite directions, as with the left (referring to the illustration of Fig. 6 ) pointing pump head is indicated.
  • the centrifugal pump 15b operates, when it runs in the opposite direction of rotation, as a pressure reducer, in particular as an adjustable pressure reducer.
  • the inlet and outlet of the centrifugal pump 15b may be reversed.
  • An "exchange" of inlet and outlet can be done in various ways. Examples of this are a reverse installation of the centrifugal pump, a provision of appropriately arranged and controlled valves and the like.
  • valves With appropriately arranged and controlled valves, these can preferably be actuated by actuators of a dialysis machine via a flexible membrane, e.g. by impressing and / or releasing the relevant fluid paths.
  • the direction reversal can be provided in addition or alternatively.
  • the considered conveyor may be provided and configured to operate in one or two opposite directions.
  • Fig. 7 shows a centrifugal pump 15a with an impeller 25 as a rotating section, a rotor 27, coils 29 and a stator 31.
  • the centrifugal pump 15a has a housing 32 with an inlet and an outlet (indicated by arrows in FIG Fig. 7 recognizable as such).
  • the centrifugal pump 15a is flowed through in the flow direction shown.
  • the drive of the impeller 25 is effected by a circulating electromagnetic field, generated by means of driving the coils 29 of the stator 31st
  • impeller magnets or at least ferromagnetic materials may be integrated.
  • the bearing of the impeller 25 can then take place on the one hand by means of the impeller magnets and on the other hand by means provided outside of the centrifugal pump magnets.
  • the magnets may be arranged circumferentially in the same rotational movement as the impeller 25.
  • a rotating electromagnetic field in a coil arrangement store the impeller 25 and fix it in a stable circumferential position.
  • Fig. 8 schematically shows a simplified balancing device 100 according to the invention and a treatment device 300 according to the invention with a dialyzer 33 with a blood inlet 33a and a blood outlet 33b, and other elements.
  • Fig. 9 shows in reference to the Fig. 1 schematically simplifies an inventive balancing a another embodiment during a first power stroke.
  • the centrifugal pump 15b conveys in the opposite direction to the conveying direction of the centrifugal pump 15a.
  • an optionally too high inlet pressure can advantageously be counteracted or reduced. This may be the case when the dialysate is made from reverse osmosis water (RO) and concentrates.
  • RO water connection can have such a high line pressure that the balancing device could be damaged by it.

Description

Die vorliegende Erfindung betrifft eine Bilanziereinrichtung gemäß Anspruch 1. Sie betrifft ferner eine externe medizinische Funktionseinrichtung gemäß Anspruch 7 sowie eine Behandlungsvorrichtung gemäß Anspruch 10.The present invention relates to a balancing device according to claim 1. It further relates to an external medical functional device according to claim 7 and a treatment device according to claim 10.

Aus der EP 0 867 195 B1 sind Bilanziereinrichtungen zum Bilanzieren von Mengen- und/oder Volumenströmen medizinischer Fluide wie Blut oder während der Blutbehandlung eingesetzter Fluide bekannt.From the EP 0 867 195 B1 Balancing devices are known for balancing volume and / or volume flows of medical fluids such as blood or fluids used during the blood treatment.

Die US 4,997,570 A offenbart eine Bilanziereinrichtung mit einer Pumpe.The US 4,997,570 A discloses a balancing device with a pump.

Die EP 0 623 357 A1 beschreibt eine Dialysiereinrichtung mit Pumpen.The EP 0 623 357 A1 describes a dialyzer with pumps.

Die US 3,709,222 A beschreibt eine Dialysiereinrichtung mit rotierenden Peristaltikpumpen.The US 3,709,222 A describes a dialyzer with rotating peristaltic pumps.

Die EP 0 900 572 A1 offenbart eine Zentrifugalpumpe zum Fördern eines Fluids.The EP 0 900 572 A1 discloses a centrifugal pump for conveying a fluid.

Die US 2009/095679 A1 offenbart pneumatisch angetriebene Dialysatverdrängerpumpen.The US 2009/095679 A1 discloses pneumatically driven Dialysatverdrängerpumpen.

Eine Aufgabe der vorliegenden Erfindung ist es, eine weitere Bilanziereinrichtung vorzuschlagen.An object of the present invention is to propose a further balancing device.

Diese Aufgabe wird durch eine Bilanziereinrichtung zum Bilanzieren medizinischer Fluide, insbesondere zum Bilanzieren von Dialysat, mit den Merkmalen des Anspruchs 1 gelöst.This object is achieved by a balancing device for balancing medical fluids, in particular for balancing dialysate, with the features of claim 1.

Die erfindungsgemäße Bilanziereinrichtung weist wenigstens eine Bilanzierkammer und wenigstens eine Fördereinrichtung zum Befüllen der Bilanzierkammer auf.The balancing device according to the invention has at least one balancing chamber and at least one conveying device for filling the balancing chamber.

Vorteilhafte Weiterbildungen sind Gegenstand der Unteransprüche und Ausführungsformen.Advantageous developments are the subject of the subclaims and embodiments.

Bei allen folgenden Ausführungen ist der Gebrauch des Ausdrucks "kann sein" bzw. "kann haben" usw. synonym zu "ist vorzugsweise" bzw. "hat vorzugsweise" usw. zu verstehen.In all of the following, the use of the term "may be" or "may have", etc., is synonymous with "is preferably" or "preferably has" and so on.

Unter dem Begriff "Bilanzierung", wie er hierin verwendet wird, ist in einer Ausführungsform eine Gegenüberstellung von Mengen und/oder Volumina medizinischer Fluide zu verstehen, die einem Patienten oder einer Behandlungsvorrichtung zum Behandeln des Patienten zu- oder abgeführt werden.As used herein, the term "accounting" is understood, in one embodiment, to be a comparison of amounts and / or volumes of medical fluids that are delivered to or removed from a patient or treatment device for treating the patient.

Der Begriff "Patient", wie er hierin verwendet wird, bezeichnet einen Menschen oder ein Tier, gleich ob krank oder gesund.The term "patient" as used herein refers to a human or an animal, whether ill or healthy.

Eine "Bilanzierkammer" im Sinne der vorliegenden Erfindung bezeichnet eine Einrichtung, welche dazu vorgesehen ist, die zur Bilanzierung vorgesehenen medizinischen Fluide - oder Teilmengen derselben - in einem Inneren bzw. Innenvolumen aufzunehmen.A "balancing chamber" in the sense of the present invention refers to a device which is provided to receive the medical fluids to be balanced - or partial quantities thereof - in an inner or inner volume.

Die Bilanzierkammer ist in einer erfindungsgemäßen Ausführungsform eine Kammer, die durch wenigstens eine Trennwand oder Membran, welche verschiebbar oder flexibel ausgestaltet sein kann, in wenigstens zwei Bilanzierkammerhälften oder -abschnitte unterteilt ist. Wenigstens eine der Bilanzierkammerhälften oder-abschnitte kann vorgesehen sein, zugeführte bzw. frische medizinische Fluide aufzunehmen. Wenigstens eine weitere Bilanzierkammerhälfte oder ein weitererThe balancing chamber in one embodiment according to the invention is a chamber which is subdivided into at least two balancing chamber halves or sections by at least one dividing wall or membrane, which can be designed to be displaceable or flexible. At least one of the balancing chamber halves or sections may be provided to receive supplied or fresh medical fluids. At least one more balancing chamber half or another

Bilanzierkammerabschnitt kann vorgesehen sein, abgeführte bzw. verbrauchte medizinische Fluide aufzunehmen.Balancing section may be provided to receive discharged medical fluids.

Die Bilanziereinrichtung kann mehr als eine Bilanzierkammer, d.h. z.B. zwei, drei, vier oder mehr Bilanzierkammern, aufweisen.The balancing means may comprise more than one balancing chamber, i. e.g. two, three, four or more balancing chambers.

Mehrere, z.B. zwei, Bilanzierkammern können beispielsweise vorteilhaft dazu eingesetzt werden, einen kontinuierlichen Fluss der medizinischen Fluide während der Bilanzierung sicherzustellen.Several, e.g. For example, two balancing chambers can be advantageously used to ensure a continuous flow of medical fluids during balancing.

Die Bilanzierkammern können miteinander in Fluidverbindung stehen oder nicht. Die Bilanzierkammern können gemeinsam oder getrennt voneinander befüll-und/oder entleerbar sein.The balancing chambers may or may not be in fluid communication with each other. The balancing chambers can be filled and / or emptied together or separately.

Jede Bilanzierkammer kann (eine oder mehrere) Zuführleitungen für zugeführte oder frische medizinische Fluide und (eine oder mehrere) mit einem Auslass verbundene Abführleitungen für abgeleitete verbrauchte medizinische Fluide aufweisen. In den Zuführ- und/oder in den Abführleitungen können Absperrventile angeordnet sein.Each balancing chamber may include (one or more) supply lines for supplied or fresh medical fluids and (one or more) outlet lines for drained spent medical fluids connected to an outlet. In the supply and / or in the discharge lines shut-off valves can be arranged.

Beispiele für solche Absperrventile schließen Aktuatoren, welche aus einem Abschnitt einer Maschine, wie einer Behandlungsvorrichtung, heraus- und/oder hereinfahrbar sind, ein. Mittels dieser Aktuatoren kann es möglich sein, einen Fluidstrom innerhalb eines Fluidsystems der medizinischen Fluide zu unterbinden oder freizugeben. Derartige Aktuatoren schließen die in der von der Anmelderin der vorliegenden Anmeldung am 10. Juni 2009 beim Deutschen Patent- und Markenamt hinterlegten Anmeldung 10 2009 024 468.9 mit dem Titel "Externe Funktionseinrichtung, Examples of such shut-off valves include actuators that are extendable and / or retractable from a portion of a machine, such as a treatment device. By means of these actuators it may be possible to prevent or release a fluid flow within a fluid system of the medical fluids. Such actuators include those filed in the application filed with the German Patent and Trademark Office by the Applicant of the present application on June 10, 2009 10 2009 024 468.9 entitled "External functional device,

Blatbehandlungsvorrichtung zum Aufnehmen einer erfindungsgemäßen externen Funktionseinrichtung, sowie Verfahren" als "Phantomventile" bezeichneten Aktuatoren ein. Blatbehandlungsvorrichtung for receiving an external functional device according to the invention, and methods as "phantom valves" designated actuators.

Beispiele für Bilanzierkammern gemäß einer Ausführungsform der Bilanziereinrichtung der vorliegenden Erfindung sowie deren jeweilige Funktion sind in der eingangs genannten EP 0 867 195 B1 der Anmelderin der vorliegenden Anmeldung offenbart.Examples of balancing chambers according to an embodiment of the balancing device of the present invention and their respective function are in the aforementioned EP 0 867 195 B1 the assignee of the present application.

Die Fördereinrichtung kann Teil eines Fluidsystems sein, in welchem das medizinische Fluid vorliegt bzw. enthalten ist. Die Fördereinrichtung kann z.B. zum Fördern des medizinischen Fluids in das Fluidsystem eingebaut bzw. geschaltet sein. Die Fördereinrichtung kann in ihrem Gebrauch von dem zu bilanzierenden medizinischen Fluid durchströmt sein.The conveyor may be part of a fluid system in which the medical fluid is present. The conveyor may e.g. be installed or switched to convey the medical fluid in the fluid system. The conveyor may be flowed through in its use of the medical fluid to be balanced.

Das Fluidsystem kann Leitungen, Schläuche, Schlauchsysteme, Kanäle, Kammern, Ausbuchtungen, Einrichtungen oder Räume oder Bereiche zum Speichern oder Vorhalten oder Zurückhalten von Fluiden sowie Steuer- oder Regeleinrichtungen zum Steuern oder Regeln eines Strömungsdurchflusses der Fluide und dergleichen aufweisen.The fluid system may include conduits, hoses, tubing, channels, chambers, protrusions, devices or spaces or areas for storing or holding or retaining fluids, and control devices for controlling or controlling a flow rate of the fluids and the like.

Das Fluidsystem ist in bestimmten Ausführungsformen für eine Dialysierflüssigkeit vorgesehen.The fluid system is provided in certain embodiments for a dialysis fluid.

Das Fluidsystem ist in bestimmten Ausführungsformen für Blut in einem extrakorporalen Blutkreislauf oder andere Fluide vorgesehen. Die anderen Fluide umfassen eine Citrat- und/oder Calciumlösung, Wasser oder eine Hydraulikflüssigkeit.The fluid system, in certain embodiments, is for blood in extracorporeal blood circulation or other fluids intended. The other fluids include citrate and / or calcium solution, water or hydraulic fluid.

Der in der Bilanzierkammer beim Befüllen herrschende Druck wird im Folgenden als Fülldruck bezeichnet. Er kann veränderbar sein. Er kann ansteigend sein. Er kann zu verschiedenen Momenten unterschiedlich groß sein.The pressure prevailing in the balancing chamber during filling is referred to below as filling pressure. He can be changeable. He can be rising. He can be different in size at different moments.

In einer Ausführungsform ist ein maximaler Fülldruck der erfindungsgemäßen Bilanziereinrichtung über eine eingestellte Drehzahl der Fördereinrichtung festlegbar. Der maximale Fülldruck kann durch die Kennlinie der Fördereinrichtung, z.B. eine Pumpenkennlinie, vorgegeben sein.In one embodiment, a maximum filling pressure of the balancing device according to the invention can be fixed over a set speed of the conveyor. The maximum inflation pressure may be determined by the characteristic of the conveyor, e.g. a pump characteristic, be specified.

In einer Ausführungsform wird der Fluss und/oder der Förderdruck der Fördereinrichtung durch geeignete Mittel gemessen. Entsprechende Mittel können dazu konfiguriert und vorgesehen sein.In one embodiment, the flow and / or delivery pressure of the conveyor is measured by suitable means. Corresponding means can be configured and provided for this purpose.

Der maximale Fülldruck zum Befüllen der Bilanzierkammer der Bilanziereinrichtung kann vorgegeben sein. Der maximale Fülldruck ist in einer erfindungsgemäßen Ausführungsform durch Änderung der Betriebsparameter der Fördereinrichtung (z. B. mittels einer Beeinflussung der Drehzahl einer Pumpe) einstellbar bzw. wird eingestellt.The maximum filling pressure for filling the balancing chamber of the balancing device can be predetermined. In one embodiment according to the invention, the maximum filling pressure can be set or adjusted by changing the operating parameters of the conveying device (for example by influencing the rotational speed of a pump).

In einer weiteren erfindungsgemäßen Ausführungsform sind die Betriebsparameter der Fördereinrichtung (z. B. mittels einer Beeinflussung der Drehzahl einer Pumpe) durch eine Änderung eines magnetischen Feldes einstellbar bzw. wird eingestellt.In a further embodiment according to the invention, the operating parameters of the conveying device (eg by influencing the rotational speed of a pump) can be set or adjusted by changing a magnetic field.

Der maximale Fülldruck kann in einer Ausführungsform nach seinem Erreichen von der Fördereinrichtung für eine Zeit konstant gehalten werden oder, in einer anderen Ausführungsform, abfallen. Dies kann in Abhängigkeit der Vorlast geschehen.The maximum inflation pressure may, in one embodiment, after it has been reached by the conveyor for a time kept constant or, in another embodiment, fall off. This can be done depending on the preload.

Der maximale Fülldruck kann beispielsweise erreicht sein, wenn die Bilanzierkammer im Wesentlichen oder vollständig mit dem oder den zu bilanzierenden medizinischen Fluiden gefüllt oder befüllt ist.The maximum filling pressure can be achieved, for example, when the balancing chamber is substantially or completely filled or filled with the medical fluid (s) to be balanced.

Der maximale Fülldruck kann auch erreicht sein, wenn eine Bilanzierkammerhälfte oder ein Bilanzierkammerabschnitt durch Betreiben der Fördereinrichtung im Wesentlichen oder vollständig befüllt wurde.The maximum inflation pressure may also be reached when a balancing chamber half or balancing chamber section has been substantially or completely filled by operating the conveyor.

Die "druckbegrenzte Fördereinrichtung" ist in einer Ausführungsform der erfindungsgemäßen Bilanziereinrichtung eine Fördereinrichtung, welche nach Erreichen eines maximalen Drucks oder Fülldrucks keinen höheren Druck im Inneren der Bilanzierkammer mehr aufbaut.In one embodiment of the balancing device according to the invention, the "pressure-limited conveying device" is a conveying device which, after reaching a maximum pressure or filling pressure, does not build up any higher pressure in the interior of the balancing chamber.

Die "druckbegrenzte Fördereinrichtung" ist in einer anderen Ausführungsform der erfindungsgemäßen Bilanziereinrichtung eine Pumpe, deren Laufrad bei Erreichen des maximalen Fülldrucks vom geförderten Fluid überströmt wird.The "pressure-limited conveyor" is in another embodiment of the balancing device according to the invention, a pump, the impeller is flowed over upon reaching the maximum filling pressure of the pumped fluid.

Die "druckbegrenzte Fördereinrichtung" ist in einer weiteren Ausführungsform der erfindungsgemäßen Bilanziereinrichtung eine Fördereinrichtung, welche in wenigstens einem Betriebszustand als Konstantdruckquelle oder als Druckquelle mit konstantem oder annähernd konstantem Druck betrieben werden kann.The "pressure-limited conveyor" is in a further embodiment of the balancing device according to the invention a conveyor, which can be operated in at least one operating state as a constant pressure source or as a pressure source with constant or approximately constant pressure.

Die "druckbegrenzte Fördereinrichtung" ist in einer weiteren Ausführungsform der erfindungsgemäßen Bilanziereinrichtung eine Fördereinrichtung, welche wenigstens eine Pumpe aufweist oder aus einer solchen besteht, wobei die Pumpe keine Überströmventile und/oder Bypassleitungen aufweist oder mit solchen funktionell verbunden ist.In a further embodiment of the balancing device according to the invention, the "pressure-limited conveying device" is a conveying device which comprises or consists of at least one pump, wherein the pump has no overflow valves and / or bypass lines or is functionally connected to such.

Die "druckbegrenzte Fördereinrichtung" ist in einer weiteren Ausführungsform der erfindungsgemäßen Bilanziereinrichtung eine Fördereinrichtung, welche nicht mit einer Steuereinrichtung zu dem Zweck verbunden ist - und/oder keine zu diesem Zweck vorgesehene und entsprechende konfigurierte Steuereinrichtung aufweist -, eine Druckbegrenzung der Fördereinrichtung in Abhängigkeit mit einem während der Befüllung der Bilanzierkammer des in dieser herrschenden Fülldrucks vorzunehmen.The "pressure-limited conveyor" is in a further embodiment of the balancing device according to the invention, a conveyor which is not connected to a control device for the purpose - and / or provided for this purpose and corresponding configured control device -, a pressure relief of the conveyor depending on a during the filling of the balancing chamber to make the prevailing in this filling pressure.

Die "druckbegrenzte Fördereinrichtung" ist in der erfindungsgemäßen Bilanziereinrichtung eine Pumpe, welche aufgrund ihrer Bauart keinen Druck über einen vorbestimmten Druck hinaus - hier den Fülldruck - aufbaut. Sie wird hierin in wenigstens einer Ausführungsform der erfindungsgemäßen Bilanziereinrichtung durch keine weiteren Elemente, insbesondere keine Steuerung, Schaltung, Ventile, Bypassüberdruckventile, Druckmesseinrichtungen und dergleichen, jeweils direkt oder indirekt, unterstützt.The "pressure-limited conveyor" is in the balancing device according to the invention, a pump which due to their design no pressure above a predetermined pressure addition - here the filling pressure - builds. It is here in at least one embodiment of the balancing device according to the invention by any other elements, in particular no control, circuit, valves, bypass pressure relief valves, pressure measuring devices and the like, each directly or indirectly supported.

Die "druckbegrenzte Fördereinrichtung" ist in einer Ausführungsform der erfindungsgemäßen Bilanziereinrichtung eine Fördereinrichtung, bei deren Einsatz nach Erreichen eines maschinenseitig eingestellten maximalen Drucks oder Fülldrucks die von ihr befüllte Bilanzierkammer als volumenstarre Kammer angenommen werden kann.In one embodiment of the balancing device according to the invention, the "pressure-limited conveying device" is a conveying device, in the use of which the balancing chamber filled by it can be assumed to be a volume-stable chamber after reaching a maximum pressure or filling pressure set on the machine side.

Die Bilanziereinrichtung weist in einer erfindungsgemäßen Ausführungsform mehrere Fördereinrichtungen auf.The balancing device has, in an embodiment according to the invention, several conveying devices.

Die Bilanziereinrichtung weist in einer erfindungsgemäßen Ausführungsform keine Überströmventile, Bypassleitungen, Steuerungen, Schaltungen, Ventile, Bypassüberdruckventile, Druckmesseinrichtungen und dergleichen auf, welche zum Begrenzen des Förderdrucks der Fördereinrichtung geeignet und vorgesehen oder konfiguriert sind.In one embodiment of the invention, the balancing means does not comprise overflow valves, bypass lines, controls, circuits, valves, bypass overpressure valves, pressure measuring devices and the like which are suitable and intended or configured for limiting the delivery pressure of the delivery device.

Die Bilanziereinrichtung weist in einer erfindungsgemäßen Ausführungsform keine Rollenpumpe oder Zahnradpumpe mit Bypassventil und/oder Druckregelung auf.The balancing device has in an embodiment according to the invention no roller pump or gear pump with bypass valve and / or pressure control.

Weist die erfindungsgemäße Bilanziereinrichtung mehrere Fördereinrichtungen auf, so können diese in einer Ausführungsform gleichartig oder unterschiedlich ausgestaltet sein.If the balancing device according to the invention has a plurality of conveying devices, they can be configured identically or differently in one embodiment.

In einer erfindungsgemäßen Ausführungsform der Bilanziereinrichtung weist diese mehrere, in Reihe geschaltete Fördereinrichtungen auf. Auf diese Weise kann es vorteilhaft möglich sein, die Bilanzierkammer gezielt zu entlasten.In one embodiment of the balancing device according to the invention, this has a plurality of conveyors connected in series. In this way, it may be advantageous to specifically relieve the balancing chamber.

Die einzelnen Fördereinrichtungen sind in einer erfindungsgemäßen Ausführungsform der Bilanziereinrichtung angeordnet, um in die gleiche Förderrichtung zu laufen bzw. betrieben zu werden bzw. um in der gleichen Richtung fördern.The individual conveying devices are arranged in an embodiment according to the invention of the balancing device in order to run or be operated in the same conveying direction or to convey in the same direction.

In einer erfindungsgemäßen Ausführungsform laufen die Fördereinrichtungen in verschiedenen Richtungen bzw. fördern in entgegengesetzte Richtungen. Hierbei kann es vorteilhaft möglich sein, gezielt Druck aufzubauen und/oder den Volumenstrom der medizinischen Fluide zu begrenzen. Dies kann vorteilhaft dazu beitragen, die auf die Bilanzierkammmer wirkenden Kräfte weiter zu verringern. Insbesondere kann es vorteilhaft möglich sein, die auf die Bilanzierkammer und deren Wände wirkenden Kräfte zu verringern oder gar zu minimieren.In one embodiment of the invention, the conveyors run in different directions or promote in opposite directions. In this case, it may be advantageously possible to deliberately build up pressure and / or limit the volume flow of the medical fluids. This can advantageously contribute to further reducing the forces acting on the balancing chamber. In particular, it may be advantageously possible to reduce or even minimize the forces acting on the balancing chamber and its walls.

In einer erfindungsgemäßen Ausführungsform laufen wenigstens zwei Fördereinrichtungen in derselben Richtung bzw. fördern in derselben Richtung. Hierbei kann es vorteilhaft möglich sein, gezielt Druck abzubauen. Auch dies kann vorteilhaft dazu beitragen, die auf die Bilanzierkammer wirkenden Kräfte weiter zu verringern (Entlastung der Kammer). Insbesondere kann es vorteilhaft möglich sein, die auf die Bilanzierkammer und deren Wände wirkenden Kräfte zu verringern oder gar zu minimieren.In an embodiment according to the invention, at least two conveyors run in the same direction or convey in the same direction. In this case, it may be advantageously possible to selectively reduce pressure. This too can advantageously contribute to further reducing the forces acting on the balancing chamber (discharge of the chamber). In particular, it may be advantageously possible to reduce or even minimize the forces acting on the balancing chamber and its walls.

Eine "Zentrifugalpumpe" oder eine Kreiselpumpe kann in einer Ausführungsform vorteilhaft einen hohen Volumenstrom bei niedrigen Drücken und/oder einen niedrigen Volumenstrom bei hohen Drücken bereitstellen.In one embodiment, a "centrifugal pump" or a centrifugal pump can advantageously provide a high volume flow at low pressures and / or a low flow rate at high pressures.

Die Zentrifugalpumpe ist in einer erfindungsgemäßen Ausführungsform eine Axialpumpe mit den dem Fachmann im Zusammenhang mit Axialpumpen bekannten Vorteilen.The centrifugal pump in an embodiment according to the invention is an axial pump with the advantages known to the person skilled in the art in connection with axial pumps.

Die Zentrifugalpumpe ist in einer weiteren erfindungsgemäßen Ausführungsform eine Radialpumpe oder eine Diagonalpumpe mit den dem Fachmann im Zusammenhang mit Radialpumpen bzw. Diagonalpumpen bekannten Vorteilen.In a further embodiment according to the invention, the centrifugal pump is a radial pump or a diagonal pump with the advantages known to the person skilled in the art in connection with radial pumps or diagonal pumps.

Der maximale Druck der Zentrifugalpumpe - und damit der maximale Fülldruck - kann über die Drehzahl, z.B. mittels Drehzahlbegrenzung, eingestellt werden, so dass die maximale Druckbelastung auf das gesamte System vorteilhaft (sehr) exakt definierbar sein kann.The maximum pressure of the centrifugal pump - and thus the maximum filling pressure - can be determined by the speed, e.g. be set by means of speed limitation, so that the maximum pressure load on the entire system can be advantageous (very) exactly defined.

Die Zentrifugalpumpe kann die Eigenschaft aufweisen, dass ab einem gewissen Fluiddruck, z.B. wenn die Bilanzierkammer vollständig gefüllt ist, eine Überströmung des Laufrads bzw. des Rotationsabschnitts auftritt. Diese Überströmung kann eine Druckbegrenzung im geförderten Fluid zur Folge haben, derart, dass die Zentrifugalpumpe druckbegrenzt im Sinne der vorliegenden Erfindung arbeitet.The centrifugal pump may have the characteristic that, starting from a certain fluid pressure, e.g. when the balancing chamber is completely filled, an overflow of the impeller or the rotation section occurs. This overflow can result in a pressure limitation in the conveyed fluid, such that the centrifugal pump operates under pressure limitation in the sense of the present invention.

Zum Erzielen der Druckbegrenzung bedarf die Zentrifugalpumpe in einer Ausführungsform vorteilhafter Weise keiner Unterstützung durch weitere Bauteile wie Steuerung, Regelung, Ventile, usw.To achieve the pressure limiting the centrifugal pump in one embodiment advantageously requires no support by other components such as control, regulation, valves, etc.

Unter einer Druckquelle wird erfindungsgemäß jegliche Fluidförderungsvorrichtung verstanden, deren Ausgangsfluiddruck konstant oder im Wesentlichen konstant ist.A pressure source is understood according to the invention to mean any fluid delivery device whose output fluid pressure is constant or substantially constant.

In einer weiteren bevorzugten Ausführungsform weist die Fördereinrichtung wenigstens einen drehenden bzw. rotierenden Abschnitt bzw. einen Rotationsabschnitt auf. Dieser ist in einer erfindungsgemäßen Ausführungsform mechanisch gelagert, in einer anderen ist er magnetisch gelagert.In a further preferred embodiment, the conveying device has at least one rotating or rotating section or one rotating section. This is mechanically stored in one embodiment of the invention, in another it is magnetically supported.

Der Rotationsabschnitt kann ausschließlich oder ergänzend magnetisch gelagert sein.The rotation section may be exclusively or additionally magnetically mounted.

Der Rotationsabschnitt kann in einem Inneren der Fördereinrichtung angeordnet sein.The rotation section may be arranged in an interior of the conveyor.

Der Rotationsabschnitt kann im Gebrauch vollständig von den durch die Fördereinrichtung strömenden medizinischen Fluiden umspült sein.The rotating section may be completely immersed in use by the medical fluids flowing through the conveyor during use.

Der Rotationsabschnitt ist in einer Ausführungsform ein Laufrad oder ein Rotor.The rotating section is an impeller or a rotor in one embodiment.

In einer weiteren Ausführungsform weist die Fördereinrichtung wenigstens einen Rotationsabschnitt auf, welcher vorgesehen und ausgestaltet ist, um mittels eines externen Antriebs magnetisch oder mittels eines elektrischen Feldes antreibbar zu sein oder betrieben zu werden.In a further embodiment, the conveying device has at least one rotary section, which is provided and configured to be drivable or operated by means of an external drive magnetically or by means of an electric field.

In einer weiteren Ausführungsform ist der externe Antrieb des Rotationsabschnitts ausgestaltet, um mechanisch, z.B. über lösbare, fluiddichte Kupplungen angetrieben zu werden.In a further embodiment, the external drive of the rotary section is configured to be driven mechanically, eg via detachable, fluid-tight couplings.

Der Begriff "externer Antrieb", wie er hierin verwendet wird, bezeichnet einen Antrieb für den Rotationsabschnitt, welcher Teil der Bilanziereinrichtung sein kann, nicht aber Teil sein muss.The term "external drive" as used herein refers to a drive for the rotating section, which may be part of the balancing device but need not be part.

Der externe Antrieb kann an einer Vorrichtung, welche mit einer erfindungsgemäßen Bilanziereinrichtung zusammenwirkt, wie einer Behandlungsvorrichtung, angeordnet sein. Der externe Antrieb kann Teil der Vorrichtung sein.The external drive can be arranged on a device which cooperates with a balancing device according to the invention, such as a treatment device. The external drive may be part of the device.

Die magnetische Antriebskraft oder -wirkung kann mit Hilfe eines oder mehrerer Magneten erzielt werden. Sie kann mit Hilfe von stromdurchflossenen Leitern erzielt werden. Beispielsweise können stromdurchflossene Spulen verwendet werden.The magnetic driving force or effect can be achieved by means of one or more magnets. It can be achieved with the help of current-carrying conductors. For example, current-carrying coils can be used.

Die Fördereinrichtung ist in einer erfindungsgemäßen Ausführungsform der Bilanziereinrichtung eine magnetisch gelagerte Zentrifugalpumpe, wie sie beispielsweise in der EP 0 900 572 A1 offenbart ist.In one embodiment of the balancing device according to the invention, the conveying device is a magnetically mounted centrifugal pump, as used, for example, in US Pat EP 0 900 572 A1 is disclosed.

Eine solche magnetisch gelagerte Zentrifugalpumpe kann wie jede andere magnetisch gelagerte Fördereinrichtung im Sinne der vorliegenden Erfindung den Vorteil bieten, dass keine mechanische und/oder elektrische Schnittstelle zur Maschine erforderlich ist und/oder keine Fluide von der Maschine bzw. der Behandlungsvorrichtung zur Pumpe übertragen werden müssen.Such a magnetically mounted centrifugal pump, like any other magnetically mounted conveyor in the context of the present invention, can offer the advantage that no mechanical and / or electrical interface to the machine is required and / or no fluids have to be transferred from the machine or the treatment device to the pump ,

In einer weiteren bevorzugten Ausführungsform ist das medizinische Fluid ausgewählt aus Dialysierflüssigkeit, Blut, Substituatflüssigkeit, Medikamenten, Medikamentenzubereitungen sowie Mischungen oder Kombinationen derselben.In a further preferred embodiment, the medical fluid is selected from dialysis fluid, blood, substituate fluid, medicaments, Drug preparations and mixtures or combinations thereof.

Insbesondere ist eine Bilanzierung in einer erfindungsgemäßen Ausführungsform auf der Dialysatseite während einer Dialyse erfindungsgemäß angedacht.In particular, balancing in an embodiment according to the invention on the dialysate side during dialysis is envisaged according to the invention.

In einer erfindungsgemäßen Ausführungsform ist eine Bilanzierung auf der Blutseite während einer Dialyse erfindungsgemäß angedacht.In one embodiment of the invention, balancing on the blood side during dialysis is envisaged according to the invention.

Weitere Fluide, die zu einer Bilanzierung im Rahmen einer Blutbehandlung eines Patienten von Interesse und/oder erforderlich sein können, schließen Lösungen bzw. in gelöster Form vorliegende Stoffwechselprodukte des Patienten, wie beispielsweise harnpflichtige Substanzen, und dergleichen ein.Other fluids which may be required to be included in the blood treatment of a patient of interest and / or include solutions or diseased metabolic products of the subject, such as urinary substances, and the like.

In einer weiteren bevorzugten Ausführungsform ist wenigstens eine erste Fördereinrichtung vorgesehen, um in einer ersten Richtung zu fördern. Es ist ferner wenigstens eine zweite Fördereinrichtung vorgesehen, um in einer zweiten, der ersten entgegengesetzten Richtung, zu fördern.In a further preferred embodiment, at least one first conveyor is provided to convey in a first direction. There is further provided at least a second conveyor to promote in a second, the first opposite direction.

Die Aufgabe der vorliegenden Erfindung wird ferner durch eine externe medizinische Funktionseinrichtung gemäß Anspruch 7 gelöst. Alle mit der erfindungsgemäßen Bilanziereinrichtung erzielbaren Vorteile lassen sich in bestimmten Ausführungsformen ungeschmälert auch mit der erfindungsgemäßen externen medizinischen Funktionseinrichtung erzielen, welche wenigstens eine erfindungsgemäße Bilanziereinrichtung aufweist.The object of the present invention is further achieved by an external medical functional device according to claim 7. All achievable with the balancing device according to the invention advantages can be achieved in certain embodiments undiminished even with the external medical functional device according to the invention, which has at least one balancing device according to the invention.

In einer Ausführungsform der vorliegenden Erfindung ist die externe medizinische Funktionseinrichtung als externer Flüssigkeitskreislauf mit Dialysat- und extrakorporalem Blutkreislauf, oder ist als Blut- bzw. Dialysatkassette oder kombinierte Blut-/Dialysatkassette ausgestaltet. Die externe medizinische Funktionseinrichtung kann z.B. eine Blut- bzw. Dialysatkassette oder eine kombinierte Blut-/Dialysatkassette für die Dialyse sein.In one embodiment of the present invention, the external medical device is an external fluid circuit with dialysate and extracorporeal blood circulation, or is designed as a blood or dialysate cassette or combined blood / dialysate cassette. The external medical functional device may e.g. a blood or dialysate cassette or a combined blood / dialysate cassette for dialysis.

In einer erfindungsgemäßen Ausführungsform ist die externe medizinische Funktionseinrichtung ein Disposable, ein Einmalartikel oder ein Ein-Weg-Produkt.In one embodiment of the invention, the external medical device is a disposable, disposable, or disposable product.

In einer erfindungsgemäßen Ausführungsform ist die externe medizinische Funktionseinrichtung eine Disposable-Kassette.In one embodiment of the invention, the external medical device is a disposable cassette.

Die Disposable-Kassette kann ein Hartteil sein. Sie kann aus einem Kunststoffmaterial hergestellt sein. Die Disposable-Kassette kann mittels eines Spritzgussverfahrens hergestellt sein.The disposable cassette can be a hard part. It can be made of a plastic material. The disposable cassette may be made by an injection molding process.

Die Aufgabe der vorliegenden Erfindung wird ferner durch eine Behandlungsvorrichtung gemäß Anspruch 10 gelöst. Alle mit der erfindungsgemäßen Bilanziereinrichtung erzielbaren Vorteile können in bestimmten Ausführungsformen ungeschmälert auch mit der erfindungsgemäßen Behandlungsvorrichtung erzielt werden.The object of the present invention is further achieved by a treatment device according to claim 10. All achievable with the balancing device according to the invention advantages can be achieved undiminished in certain embodiments, even with the treatment device according to the invention.

Die erfindungsgemäße Behandlungsvorrichtung ist zum Behandeln medizinischer Fluide geeignet. Sie ist dazu ausgestaltet, wenigstens eine erfindungsgemäße Bilanziereinrichtung zu betreiben.The treatment device according to the invention is suitable for the treatment of medical fluids. It is designed to operate at least one balancing device according to the invention.

Zumindest zu diesem Zweck kann die Behandlungsvorrichtung eine Steuer- oder Regeleinrichtung aufweisen. Die Steuer- oder Regeleinrichtung kann ein Mikroprozessor sein oder einen solchen aufweisen.At least for this purpose, the treatment device may have a control or regulating device. The control or regulating device may be a microprocessor or have such a microprocessor.

In einer bevorzugten Ausführungsform der erfindungsgemäßen Behandlungsvorrichtung weist die Behandlungsvorrichtung eine Einrichtung auf, die dazu vorgesehen und konfiguriert ist, die Fördereinrichtung der Bilanziereinrichtung über eine magnetische Antriebsschnittstelle anzutreiben.In a preferred embodiment of the treatment device according to the invention, the treatment device has a device which is provided and configured to drive the delivery device of the balancing device via a magnetic drive interface.

Die Einrichtung kann beispielsweise ein Magnet oder ein magnetisch wirkendes System und/oder ein stromdurchflossener Leiter, wie beispielsweise eine oder mehrere stromdurchflossene Spulen, sein oder diese aufweisen.The device may be, for example, a magnet or a magnetically acting system and / or a current-carrying conductor, such as one or more current-carrying coils, or have these.

Die Behandlungsvorrichtung kann funktionell mit einer erfindungsgemäßen Bilanziereinrichtung und/oder mit einer erfindungsgemäßen externen medizinischen Funktionseinrichtung verbunden sein.The treatment device may be functionally connected to a balancing device according to the invention and / or to an external medical functional device according to the invention.

Die erfindungsgemäße Behandlungsvorrichtung weist in einer erfindungsgemäßen Ausführungsform wenigstens eine erfindungsgemäße Bilanziereinrichtung auf.The treatment device according to the invention comprises in an embodiment according to the invention at least one balancing device according to the invention.

Die erfindungsgemäße Behandlungsvorrichtung ist in einer erfindungsgemäßen Ausführungsform mit der erfindungsgemäßen Bilanziereinrichtung fest verbunden.The treatment device according to the invention is firmly connected in one embodiment according to the invention with the balancing device according to the invention.

Eine wiederholte Benutzung der fest verbundenen erfindungsgemäßen Bilanziereinrichtung ist in einer erfindungsgemäßen Ausführungsform vorgesehen.A repeated use of the firmly connected balancing device according to the invention is provided in an embodiment according to the invention.

Die erfindungsgemäße Behandlungsvorrichtung ist in einer erfindungsgemäßen Ausführungsform eine Hämodialyseeinrichtung.The treatment device according to the invention is a hemodialysis device in one embodiment according to the invention.

Die Behandlungsvorrichtung weist in bestimmten Ausführungsformen ferner weitere Einrichtungen auf oder ist zur Koppelung mit diesen vorgesehen. Zu ihnen zählen beispielsweise ein extrakorporaler Blutkreislauf, Steuer- oder Regeleinrichtungen zum Ansteuern der Durchführung einer medizinischen Behandlung, Einrichtungen zum Überwachen und/oder Anzeigen einer Bilanzierung der während einer medizinischen Behandlung eingesetzten und/oder zirkulierten medizinischen Fluide, Einrichtungen zum Anzeigen oder Darstellen von Zuständen und/oder Parametern der medizinischen Behandlung oder der Bilanzierung, wie Bildschirmen und dergleichen, Einrichtungen zum Bedienen bzw. Betätigen oder Ansteuern einer oder mehrerer Komponenten der Behandlungsvorrichtung, wie Tastaturen und dergleichen, um z.B. die Durchführung einer medizinischen Behandlung zu veranlassen, und dergleichen.The treatment device further includes, in certain embodiments, further means or is provided for coupling therewith. These include, for example, an extracorporeal blood circulation, control or regulating devices for triggering the execution of a medical treatment, devices for monitoring and / or displaying a balance of the medical fluids used and / or circulated during a medical treatment, devices for displaying or displaying states, and / or parameters of the medical treatment or the balance, such as screens and the like, means for operating or driving one or more components of the treatment device, such as keyboards and the like, for example to initiate medical treatment, and the like.

In einer erfindungsgemäßen Ausführungsform ist die Behandlungsvorrichtung eine Blutbehandlungsvorrichtung.In one embodiment of the invention, the treatment device is a blood treatment device.

Beispiele für Blutbehandlungsverfahren schließen Dialyseverfahren, wie eine Hämodialyse, insbesondere mittels Ultrafiltration, eine Hämodiafiltration, eine Peritonealdialyse, eine automatische Peritonealdialyse, und dergleichen ein. Die Blutbehandlungseinrichtung kann zum Durchführen dieser Verfahren entsprechend ausgestaltet sein.Examples of blood treatment methods include dialysis methods such as hemodialysis, especially by ultrafiltration, hemodiafiltration, peritoneal dialysis, automatic peritoneal dialysis, and the like. The blood treatment device may be designed to carry out these methods.

Die erfindungsgemäße Bilanziereinrichtung kann nicht zuletzt bei einer Peritonealdialyse vorteilhaft zur Volumenbestimmung der Dialysierflüssigkeit, die in den Peritonealbereich des Patienten geleitet und/oder von dort aus dem Patienten befördert wird, eingesetzt werden. Dabei können zum Beispiel beide Bilanzierkammerhälften einer zweigeteilten Bilanzierkammer der Bilanziereinrichtung wechselseitig mit frischer Dialysierflüssigkeit (beim Einlaufen der Dialysierflüssigkeit in den Bauchraum des Patienten) und/oder mit gebrauchter Dialysierflüssigkeit (beim Entfernen der Dialysierflüssigkeit aus dem Bauchraum des Patienten) gefüllt werden. Die bei einer Bilanzierung interessierenden Volumina und/oder Mengen der medizinischen Fluide, z.B. der Dialysierflüssigkeit, können dabei beispielsweise über die Anzahl der Befüllungen der Bilanzierkammer bestimmt werden.Not least in the case of peritoneal dialysis, the balancing device according to the invention can advantageously be used to determine the volume the dialysis fluid, which is passed into the peritoneal region of the patient and / or from there out of the patient, are used. In this case, for example, both balancing chamber halves of a two-part balancing chamber of the balancing device can be filled alternately with fresh dialysis fluid (when the dialysis fluid enters the abdominal cavity of the patient) and / or with used dialysis fluid (when removing the dialysis fluid from the patient's abdominal cavity). The volumes and / or quantities of the medical fluids, eg the dialysis fluid, which are of interest in a balancing can be determined, for example, via the number of fillings of the balancing chamber.

Ein Verfahren umfasst das Bilanzieren wenigstens eines medizinischen Fluids unter Verwenden wenigstens einer erfindungsgemäßen Bilanziereinrichtung oder wenigstens einer erfindungsgemäßen externen medizinischen Funktionseinrichtung oder wenigstens einer erfindungsgemäßen Behandlungsvorrichtung.A method comprises balancing at least one medical fluid using at least one balancing device according to the invention or at least one external medical functional device according to the invention or at least one treatment device according to the invention.

Ein Verfahren umfasst das Befüllen einer Bilanzierkammer mittels wenigstens einer Fördereinrichtung und das Betreiben der Fördereinrichtung in wenigstens einem Betriebszustand als Konstantdruckquelle.One method comprises filling a balancing chamber by means of at least one conveying device and operating the conveying device in at least one operating state as a constant pressure source.

Um die Fördereinrichtung in dem gewünschten Betriebszustand als Konstantdruckquelle zu betreiben, kann eine bestimmte Drehzahl der Fördereinrichtung eingestellt werden, bei der sich eine fixe bzw. feste oder vorgegebene Druckdifferenz über der Fördereinrichtung einstellen kann.In order to operate the conveyor in the desired operating state as a constant pressure source, a certain speed of the conveyor can be set, in which a fixed or fixed or predetermined pressure difference over the conveyor can be set.

Die vorliegende Erfindung schlägt eine Bilanziereinrichtung vor, in welcher die Fördereinrichtung nach Befüllen der Bilanzierkammer(n) als Konstantdruckquelle betrieben wird.The present invention proposes a balancing device in which the delivery device is operated as a constant pressure source after filling the balancing chamber (s).

Die Konstantdruckquelle kann vorteilhaft dazu beitragen, einen maximalen Fülldruck innerhalb der Bilanzierkammer sicherzustellen. Die baulichen Anforderungen an die Bilanzierkammer können damit geringer sein.The constant pressure source can advantageously help to ensure a maximum filling pressure within the balancing chamber. The structural requirements of the balancing chamber can thus be lower.

Allgemein kann eine Bilanziergenauigkeit vor allem von den Druckschwankungen zwischen zwei Füllvorgängen abhängen, was sich damit erklären lässt, dass der Schaltvorgang zum Beenden eines Befüllvorgangs geringfügigen Schwankungen unterliegt, und dass der Anstieg des Fülldrucks oder des Kammerinnendrucks gegen Ende der Befüllung erheblich zunimmt.In general, a balancing accuracy may depend primarily on the pressure fluctuations between two filling operations, which can be explained by the fact that the switching operation for terminating a filling process is subject to slight fluctuations, and that the increase of the filling pressure or the chamber internal pressure considerably increases towards the end of the filling.

Ferner ist bekannt, dass eine Bilanzierkammer i.a.R. nicht druckstabil ist. Aus diesem Grund kann sich das Füllvolumen verändern.It is also known that a balancing chamber i.a.R. not pressure stable. For this reason, the filling volume may change.

Da die mittels der Fördereinrichtung in die Bilanzierkammer eingebrachten medizinischen Fluide in gleichem Maße bzw. mit gleicher Geschwindigkeit oder Rate die in der Bilanzierkammer vorhandenen Fluide verdrängen können, kann es vorteilhaft möglich sein, einen konstanten oder gleichmäßigen Mengen- und/oder Volumenstrom der zu bilanzierenden Fluide zu erreichen.Since the medical fluids introduced into the balancing chamber by means of the conveying device can displace the fluids present in the balancing chamber to the same extent or at the same speed or rate, it may be advantageously possible to produce a constant or uniform volume and / or volumetric flow of the fluids to be balanced to reach.

Da über die Drehzahl und/oder den maximalen Förderdruck der Fördereinrichtung auf vorteilhaft einfache Weise eine Druckdifferenz zum Betreiben der Bilanzierkammer eingestellt werden kann, kann die druckbegrenzte Fördereinrichtung einen vorteilhaft genau regelbaren (auch dynamisch regelbaren) Bilanzierkammerdruck während der Bilanzierung der medizinischen Fluide vorgeben.Since a pressure difference for operating the balancing chamber can be set in an advantageously simple manner via the rotational speed and / or the maximum delivery pressure of the delivery device, the pressure-limited delivery device can predetermine an advantageously precisely controllable balancing chamber pressure (also dynamically controllable) during the balancing of the medical fluids.

Ein nachteiliger Druckanstieg und/oder Druckschwankungen der Bilanzierkammer können so vorteilhaft vermieden werden. Eine unerwünschte Volumenausdehnung oder -veränderung der Bilanzierkammer kann so vorteilhaft verhindert werden.An adverse increase in pressure and / or pressure fluctuations of the balancing chamber can be advantageously avoided. An undesirable volume expansion or change of the balancing chamber can be advantageously prevented.

Auf diese Weise kann es vorteilhaft möglich sein, eine Mengen- und/oder Volumengenauigkeit einer Bilanzierung zu verbessern.In this way, it may be advantageously possible to improve a quantity and / or volume accuracy of a balance.

Dies kann zum Beispiel auch vorteilhaft dazu beitragen, das Fluidvolumen, das einem Patienten während einer Behandlung, z.B. einer Ultrafiltration während einer Dialysebehandlung, über die Dialysefiltermembran entzogen wird, genau zu bestimmen und/oder auf die vom behandelnden Arzt gewünschte Rate einzustellen. Die Sicherheit und ggf. auch die Verträglichkeit einer Blutbehandlung kann so vorteilhaft weiter verbessert werden.This may also, for example, beneficially contribute to reducing the volume of fluid that can be delivered to a patient during a treatment, e.g. an ultrafiltration during a dialysis treatment, is withdrawn over the dialysis filter membrane, to determine precisely and / or set to the desired rate by the treating physician. The safety and possibly also the compatibility of a blood treatment can be further improved so advantageous.

So kann es vorteilhaft möglich sein, eine Fehlbilanzierung zu verhindern, wobei sich eine Fehlbilanzierung z.B. über die Dauer einer Blutbehandlungssitzung aufsummieren kann. Hat die Bilanzierung Auswirkung auf die durchgeführte Behandlung, so kann die mittels der erfindungsgemäßen Bilanziereinrichtung, in wenigstens einer Ausführungsform, verbesserte Bilanziergenauigkeit vorteilhaft zu einer verbesserten und/oder sichereren Behandlung - z.B. durch ein angemesseneres Einstellen einer Ultrafiltrationsrate - führen.Thus, it may be advantageously possible to prevent a false balance, with a false balance can accumulate over the duration of a blood treatment session, for example. If the balancing has an effect on the treatment carried out, the balancing device according to the invention, in at least one embodiment, can be improved Balancing accuracy advantageous for improved and / or safer treatment - eg by a more appropriate setting an ultrafiltration rate - lead.

Die Bilanzierkammer der erfindungsgemäßen Bilanziereinrichtung kann vorteilhaft als druckbegrenzte volumetrische Bilanzierkammer mit hinreichender Festigkeit eingesetzt werden.The balancing chamber of the balancing device according to the invention can be advantageously used as a pressure-limited volumetric balancing chamber with sufficient strength.

Auf aufwendige Konstruktionen, wie Verstrebungen oder verstärkte Kunststoffmaterialien oder dergleichen, mit welchen im Stand der Technik eine hinreichende Festigkeit gewährleistet werden müssen, kann bei Verwenden der erfindungsgemäßen Bilanziereinrichtung vorteilhaft verzichtet werden. Die Konstruktion der erfindungsgemäßen Bilanziereinrichtung kann somit aufgrund der vorgesehenen Druckbegrenzung mittels der Fördereinrichtung vorteilhaft vereinfacht werden.In complicated constructions, such as struts or reinforced plastic materials or the like, with which a sufficient strength must be ensured in the prior art, can be advantageously dispensed with when using the balancing device according to the invention. The construction of the balancing device according to the invention can thus be advantageously simplified due to the intended pressure limitation by means of the conveyor.

Eine Abstützung von Wänden der Bilanzkammer an festen Strukturen der Behandlungsvorrichtung ist nicht erforderlich. Die Einsatzmöglichkeiten der Bilanziereinrichtung sind damit breiter geworden ohne Einbuße ihrer Funktionsgenauigkeit.A support of walls of the balance chamber to fixed structures of the treatment device is not required. The application possibilities of the balancing device have become broader without losing their functional accuracy.

Daneben kann die Fördereinrichtung in der erfindungsgemäßen Bilanziereinrichtung vorteilhaft ohne die Verwendung von Sensoren und/oder Überströmventilen und/oder Bypassüberdruckventilen, insbesondere zum Zwecke der Druckbegrenzung in einem Inneren der Bilanzierkammer, und dergleichen auskommen. So kann es ferner vorteilhaft möglich sein, den Betrieb der Bilanziereinrichtung zu vereinfachen. Die Fördervorrichtung kann einfacher ausgestaltet sein.In addition, the conveyor in the balancing device according to the invention can advantageously manage without the use of sensors and / or overflow valves and / or bypass overpressure valves, in particular for the purpose of limiting the pressure in an interior of the balancing chamber, and the like. Thus, it may also be advantageously possible to simplify the operation of the balancing device. The conveyor device can be designed simpler.

Auf diese Weise können Abmessungen der Bilanziereinrichtung bzw. der Platzbedarf für die Bilanziereinrichtung vorteilhaft gering gehalten werden.In this way, dimensions of the balancing device and the space required for the balancing can be kept advantageously low.

Durch eine magnetische Lagerung der Fördereinrichtung kann die Konstruktion der Fördereinrichtung vorteilhaft vereinfacht werden. So kann es vorteilhaft möglich sein, auf mechanische Bauteile, wie Lager und dergleichen, zu verzichten und auf diese Weise vorteilhaft einen geringen Verschleiß der Bauteile und/oder einen geringen Partikelabrieb sicherzustellen. Hierdurch bedingt kann vorteilhaft auch eine Erwärmung der Fördereinrichtung oder der Bilanziereinrichtung vermieden oder verringert werden.By a magnetic mounting of the conveyor, the construction of the conveyor can be advantageously simplified. Thus, it may be advantageously possible to dispense with mechanical components, such as bearings and the like, and in this way advantageously ensure low wear of the components and / or low particle abrasion. As a result, heating of the conveyor device or of the balancing device can advantageously also be avoided or reduced.

Ferner kann die Fördereinrichtung der erfindungsgemäßen Bilanziereinrichtung vorteilhaft eine geringe Kavitationsneigung aufweisen.Furthermore, the conveying device of the balancing device according to the invention can advantageously have a low tendency to cavitate.

Ein weiterer Vorteil kann eine nur geringe Geräuschentwicklung beim Gebrauch der erfindungsgemäßen Bilanziervorrichtung sein.Another advantage may be a low noise during use of the balancing device according to the invention.

Da der Druck der Fördereinrichtung selbst bei anhaltendem Volumenstrom nach Abschluss der Befüllung der Bilanzierkammer nicht ansteigt, kann vorteilhaft umgangen werden, die Fördereinrichtung bei voller, d.h. im Wesentlichen oder vollständig befüllter, Bilanzierkammer abschalten zu müssen. So kann ein z.B. die Zentrifugalpumpe durchströmendes Fluid einen Rotationsabschnitt der Zentrifugalpumpe überströmen. Auf diese Weise kann eine gute Spülbarkeit (und Umspülbarkeit) der Fördereinrichtung sichergestellt werden mit einer gerichteten Strömung im durchströmten Raum der Zentrifugalpumpe.Since the pressure of the conveyor does not increase even with a sustained flow after completion of the filling of the balancing chamber, can be bypassed advantageous to have to shut down the conveyor at full, ie substantially or completely filled, balancing chamber. For example, a fluid flowing through the centrifugal pump can overflow a rotary section of the centrifugal pump. In this way, a good flushability (and Umspülbarkeit) of the conveyor can be ensured with a directed flow in the space traversed by the centrifugal pump.

Die magnetische Antriebsschnittstelle zum Betreiben der Fördereinrichtung bzw. eines Rotationsabschnitts derselben kann vorteilhaft einen berührungslosen und/oder dichtungsfreien Antrieb der Fördereinrichtung bereitstellen. Auf diese Weise kann es vorteilhaft möglich sein, auf offene Schnittstellen zwischen der Bilanziereinrichtung und der Behandlungsvorrichtung zu verzichten.The magnetic drive interface for operating the conveyor or a rotation section thereof can advantageously provide a non-contact and / or seal-free drive of the conveyor. In this way, it may be advantageously possible to dispense with open interfaces between the balancing device and the treatment device.

Somit kann es vorteilhaft möglich sein, einen besonders sicheren Betrieb der Bilanziereinrichtung sicherzustellen. Eine - wenngleich nur äußerst geringe - Kontaminationsgefahr der medizinischen Fluide kann somit vorteilhaft verringert und sogar ganz ausgeschlossen werden.Thus, it may be advantageous to ensure a particularly safe operation of the balancing device. A - although only extremely small - risk of contamination of the medical fluids can thus be advantageously reduced and even completely excluded.

Die erfindungsgemäße Bilanziereinrichtung kann vorteilhaft als Disposable, d.h. als Wegwerfartikel für den Einmalgebrauch, eingesetzt werden. Da die Fördereinrichtung als integraler Bestandteil des Disposables vorgesehen sein kann, kann sie zusammen mit dem Disposable verworfen werden, wodurch die Sicherheit und Hygiene einer medizinischen Behandlung vorteilhaft weiter verbessert werden kann.The balancing device according to the invention can advantageously be described as disposable, i. used as disposables for single use. Since the conveyor can be provided as an integral part of the disposable, it can be discarded together with the disposable, whereby the safety and hygiene of medical treatment can be advantageously further improved.

Die Verwendung von Zentrifugalpumpen hat in bestimmten Ausführungsformen gegenüber den druckgeregelten Schlauchrollen-, Zahnrad- oder Peristaltikpumpen den Vorteil der inhärenten Druckbegrenzung bei Okklusion flussabwärts der Pumpe. Der sich dort aufbauende Druck kann auf einfache Weise durch die Drehzahl eingestellt werden. Eine druckgeregelte Schlauchrollenpumpe bedarf mindestens eines Drucksensors mit Regelkreis; eine Schlauchrollenpumpe mitThe use of centrifugal pumps, in certain embodiments, has the advantage of inherently limiting the pressure upon occlusion downstream of the pump, as compared to the pressure controlled tubular roller, gear or peristaltic pumps. The pressure built up there can be easily adjusted by the speed. A pressure-controlled hose roller pump requires at least one pressure sensor with control circuit; a hose roller pump with

Überdruckbypassventil muss exakt auf den erlaubten Druck kalibriert werden. Durch Verwenden von Zentrifugalpumpen ist die erfindungsgemäße Bilanziereinrichtung in bestimmten Ausführungsformen somit weniger aufwändig.Overpressure bypass valve must be calibrated to exactly the allowed pressure. By using centrifugal pumps, the balancing device according to the invention is therefore less complicated in certain embodiments.

Im Folgenden wird die vorliegende Erfindung beispielhaft unter Bezugnahme auf die beigefügte Zeichnung beschrieben. In der Zeichnung bezeichnen gleiche Bezugszeichen gleiche oder identische Bauteile bzw. Komponenten. Es gilt:

Fig. 1
zeigt schematisch vereinfacht eine erfindungsgemäße Bilanziereinrichtung während eines ersten Arbeitstaktes;
Fig. 2
zeigt als Diagramm einen Druckverlauf in Abhängigkeit der Zeit während einer Bilanzierkammerfüllung;
Fig. 3
zeigt als Diagramm eine Druckdifferenz zwischen dem Pumpenaus- und dem Pumpeneinlass einer Zentrifugalpumpe in Abhängigkeit vom Volumenstrom;
Fig. 4
zeigt schematisch vereinfacht die erfindungsgemäße Bilanziereinrichtung der Fig. 1 während eines zweiten Arbeitstaktes;
Fig. 5
zeigt schematisch vereinfacht die erfindungsgemäße Bilanziereinrichtung der Fig. 1 mit zwei weiteren, der Bilanzierkammer nachgeschalteten Zentrifugalpumpen;
Fig. 6
zeigt schematisch vereinfacht die erfindungsgemäße Bilanziereinrichtung mit der Bilanzierkammer, Ventilen, Zentrifugalpumpen, wobei eine der nachgeschalteten Zentrifugalpumpen in einer anderen Richtung dreht;
Fig. 7
zeigt schematisch vereinfacht eine Zentrifugalpumpe mit magnetischer Lagerung und magnetischem Antrieb;
Fig. 8
zeigt schematisch vereinfacht eine erfindungsgemäße Behandlungsvorrichtung mit Bilanziereinrichtung und einer externer medizinischer Funktionseinrichtung; und
Fig. 9
zeigt schematisch vereinfacht eine erfindungsgemäße Bilanziereinrichtung einer weiteren Ausführungsform während eines ersten Arbeitstaktes.
In the following, the present invention will be described by way of example with reference to the accompanying drawings. In the drawing, like reference characters designate like or identical components. The following applies:
Fig. 1
shows schematically simplified a balancing device according to the invention during a first power stroke;
Fig. 2
shows a diagram as a pressure curve as a function of time during a balancing chamber filling;
Fig. 3
shows a diagram of a pressure difference between the Pumpenaus- and the pump inlet of a centrifugal pump as a function of the flow rate;
Fig. 4
shows schematically simplified the balancing device of the invention Fig. 1 during a second work cycle;
Fig. 5
shows schematically simplified the balancing device of the invention Fig. 1 with two further centrifugal pumps connected downstream of the balancing chamber;
Fig. 6
shows schematically simplified the balancing device according to the invention with the balancing chamber, valves, centrifugal pumps, wherein one of the downstream centrifugal pumps rotates in a different direction;
Fig. 7
shows schematically simplified a centrifugal pump with magnetic bearing and magnetic drive;
Fig. 8
schematically shows a simplified treatment device according to the invention with balancing device and an external medical functional device; and
Fig. 9
schematically shows a simplified balancing device according to the invention a further embodiment during a first power stroke.

Die Bilanziereinrichtung wird im Folgenden beispielhaft als Teil einer Blutbehandlungsvorrichtung zur Dialyse beschrieben. Es ist vorgesehen, die einem Patienten zu- und abgeführte Dialysierflüssigkeit zu bilanzieren. Prinzipiell kann jedoch auch vorgesehen sein, das Blut des Patienten zu bilanzieren.The balancing device is described below by way of example as part of a blood treatment device for dialysis. It is intended to balance the dialysis fluid supplied to and discharged from a patient. In principle, however, it can also be provided to balance the blood of the patient.

Fig. 1 zeigt eine Bilanziereinrichtung 100 gemäß der vorliegenden Erfindung mit einer Bilanzierkammer 1. Fig. 1 shows a balancing device 100 according to the present invention with a balancing chamber. 1

Wie in Fig. 1 gezeigt, ist die Bilanzierkammer 1 in eine erste Bilanzierkammerhälfte 3a und eine zweite Bilanzierkammerhälfte 3b unterteilt. Prinzipiell muss die Bilanzierkammer jedoch nicht in zwei im Wesentlichen oder vollständig gleich große Bilanzierkammerhälften aufgeteilt sein.As in Fig. 1 1, the balancing chamber 1 is divided into a first balancing chamber half 3a and a second balancing chamber half 3b. In principle, however, the balancing chamber does not have to be essentially two or three be divided completely equal balancing chamber halves.

Die erste Bilanzierkammerhälfte 3a ist durch eine fluidundurchlässige Membran 5 von der zweiten Bilanzierkammerhälfte 3b getrennt.The first balancing chamber half 3a is separated from the second balancing chamber half 3b by a fluid-impermeable membrane 5.

Die erste Bilanzierkammerhälfte 3a wird mit einem Strom 7a einer Dialysierflüssigkeit über einen Schlauch 9a befüllt. Ein Ventil 11a befindet sich dabei in geöffneter Position mittels eines Stellmechanismus 13a.The first balancing chamber half 3a is filled with a stream 7a of a dialysis fluid via a hose 9a. A valve 11a is located in the open position by means of an actuating mechanism 13a.

Die Fördereinrichtung kann eine Zentrifugalpumpe sein. Wie in Fig. 1 gezeigt, wird die erste Kammerhälfte 3a mittels einer Zentrifugalpumpe 15a befüllt.The conveyor may be a centrifugal pump. As in Fig. 1 is shown, the first chamber half 3a is filled by means of a centrifugal pump 15a.

Das Ventil 11a kann als Schlauchklemme (oder allgemein als Quetschmechanismus) ausgeführt sein. Eine solche Schlauchklemme kann durch einen elektrisch angesteuerten Aktuator geöffnet und geschlossen werden. Dies hat den Vorteil, dass das medizinische Fluid im Wesentlichen nur Kontakt mit dem Schlauch 9a, nicht jedoch mit Teilen des Ventils 11a oder dem Stellmechanismus 13a hat. Dies kann vorteilhaft dazu beitragen, eine Kontaminationsgefahr für die medizinischen Fluide zu verringern.The valve 11a can be designed as a hose clamp (or generally as a squeezing mechanism). Such a hose clamp can be opened and closed by an electrically controlled actuator. This has the advantage that the medical fluid has essentially only contact with the hose 9a, but not with parts of the valve 11a or the adjusting mechanism 13a. This can advantageously contribute to reducing the risk of contamination for the medical fluids.

Ein zweiter Strom 7b der Dialysierflüssigkeit wird durch einen Schlauch 9b aus der zweiten Bilanzierkammerhälfte 3b abgeführt. Ein Ventil 11b befindet sich dabei ebenfalls in geöffneter Position, vermittelt durch einen Stellmechanismus 13b.A second stream 7b of the dialysis fluid is discharged through a hose 9b from the second balancing chamber half 3b. A valve 11b is also in the open position, mediated by an adjusting mechanism 13b.

Die zweite Bilanzierkammerhälfte 3b kann entleert werden. Das Austragen oder Abführen von Dialysierflüssigkeit aus der zweiten Bilanzierkammerhälfte 3b kann gleichzeitig mit dem Einbringen oder Eintragen von Dialysierflüssigkeit in die erste Bilanzierkammerhälfte 3a erfolgen.The second balancing chamber half 3b can be emptied. The discharge or removal of dialysis fluid from the second balancing chamber half 3b can be carried out simultaneously with the introduction or introduction of dialysis fluid into the first balancing chamber half 3a.

Ventile 11c und 11d sind, wie in Fig. 1 gezeigt, jeweils mittels der entsprechenden Stellmechanismen 13c und 13d geschlossen. In Schläuchen 9c und 9d wird kein Fluid gefördert.Valves 11c and 11d are as in FIG Fig. 1 shown, in each case closed by means of the corresponding adjusting mechanisms 13c and 13d. No fluid is delivered in hoses 9c and 9d.

Fig. 2 zeigt ein Diagramm mit einem Druckverlauf 17 während einer Bilanzierkammerfüllung in Abhängigkeit von der Zeit. Fig. 2 shows a diagram with a pressure curve 17 during a balancing chamber filling as a function of time.

Ein Anfangsdruck bei t=0 entspricht einem Druck, mit welchem in Fig. 1, auf welche im Folgenden ebenfalls Bezug genommen wird, der Strom 7a der Dialysierflüssigkeit durch den Schlauch 9a nach Öffnen des Ventils 11a in die erste Bilanzierkammerhälfte 3a eingebracht wird. Damit der Strom 7b an Dialysierflüssigkeit durch den Schlauch 9b aus der zweiten Bilanzierkammerhälfte 3b abfließen kann, sollte das Ventil 11b geöffnet sein.An initial pressure at t = 0 corresponds to a pressure with which in Fig. 1 , which will also be referred to hereinafter, the flow 7a of the dialysis fluid is introduced through the tube 9a after opening the valve 11a in the first balancing chamber half 3a. So that the flow 7b of dialysis fluid can flow out of the second balancing chamber half 3b through the tube 9b, the valve 11b should be open.

Während die erste Bilanzierkammerhälfte 3a gefüllt und die zweite Bilanzierkammerhälfte 3b entleert wird, sinkt der Druck in der Bilanzierkammer 1 zunächst ab.While the first balancing chamber half 3a is filled and the second balancing chamber half 3b is emptied, the pressure in the balancing chamber 1 initially drops.

Wenn die erste Bilanzierkammerhälfte 3a gefüllt ist, steigt der Druck an. Ein Enddruck 18, der dem Endpunkt des Druckverlaufs bei Bilanzkammerfüllung 17 und damit dem maximalen Fülldruck entspricht, kann von dem Druck abhängen, den die Zentrifugalpumpe 15a aufbringt. Dieser Druck kann wiederum von mehreren Parametern der Zentrifugalpumpe abhängen, beispielsweise dem Bauprinzip der Zentrifugalpumpe (Radial-, Axial-, Diagonalpumpe, Laufradform, Durchmesser des Laufrads usw.) und/oder der eingestellten Drehzahl der Zentrifugalpumpe 15a und damit dem eingestellten Arbeitspunkt. Weiterhin kann der Enddruck von der Vorlast der Zentrifugalpumpe 15a abhängen, d. h., dem Druck, der an einem Dialysateinlass der Zentrifugalpumpe 15a anliegt.When the first balancing chamber half 3a is filled, the pressure increases. A final pressure 18, which corresponds to the end point of the pressure curve at balance chamber filling 17 and thus the maximum filling pressure, may depend on the pressure which the centrifugal pump 15a applies. This pressure can in turn depend on several parameters of the centrifugal pump Depending on the construction principle of the centrifugal pump (radial, axial, Diagonal pump, impeller shape, diameter of the impeller, etc.) and / or the set speed of the centrifugal pump 15a and thus the set operating point. Further, the discharge pressure may depend on the preload of the centrifugal pump 15a, that is, the pressure applied to a dialyzate inlet of the centrifugal pump 15a.

Fig. 3 zeigt ein Diagramm mit einer Druckdifferenz ΔP zwischen dem Pumpenaus- und dem Pumpeneinlass einer Zentrifugalpumpe 15a (Ordinate) in Abhängigkeit vom Volumenstrom Q der medizinischen Fluide(Abszisse). Fig. 3 shows a diagram with a pressure difference .DELTA.P between the Pumpenaus- and the pump inlet of a centrifugal pump 15a (ordinate) as a function of the volume flow Q of medical fluids (abscissa).

Bei einer Kennlinie 19 einer idealen Druckquelle, welche zum Vergleich angegeben ist, ist die Druckdifferenz ΔP unabhängig vom Volumenstrom Q. Die Höhe bzw. das Ausmaß der Druckdifferenz ΔP hängt unter anderem von der eingestellten Drehzahl einer Zentrifugalpumpe ab.In a characteristic curve 19 of an ideal pressure source, which is indicated for comparison, the pressure difference .DELTA.P is independent of the volume flow Q. The height or the extent of the pressure difference .DELTA.P depends inter alia on the set speed of a centrifugal pump.

Die tatsächlichen Druckverläufe (ΔP, Q) weichen i.d.R. von der idealen Kennlinie ab. Einen möglichen Druckverlauf einer Kennlinie für eine druckbegrenzte Fördereinrichtung wie die Zentrifugalpumpe 15a der erfindungsgemäßen Bilanziereinrichtung 100 der Fig. 1 zeigt die Kennlinie 21 einer Zentrifugalpumpe. Man erkennt, dass mittels der Zentrifugalpumpe 15a eine gute Näherung des Druckverlaufs an die ideale Kennlinie erzielbar ist. Fig. 3 zeigt auch, dass die Zentrifugalpumpe 15a als druckbegrenzte Fördereinrichtung im Sinne der vorliegenden Erfindung verstanden werden kann: der Pumpenauslass-Druck steigt ab Erreichen eines bestimmten Drucks trotz zunehmenden Volumenstroms nicht weiter an.The actual pressure curves (ΔP, Q) usually deviate from the ideal characteristic curve. A possible pressure curve of a characteristic curve for a pressure-limited conveying device such as the centrifugal pump 15a of the balancing device 100 according to the invention Fig. 1 shows the characteristic curve 21 of a centrifugal pump. It can be seen that a good approximation of the pressure curve to the ideal characteristic curve can be achieved by means of the centrifugal pump 15a. Fig. 3 also shows that the centrifugal pump 15a can be understood as a pressure-limited conveying device in the sense of the present invention: the pump outlet pressure does not increase any further after reaching a certain pressure despite increasing volume flow.

Fig. 4 zeigt die Bilanziereinrichtung 100 der Fig. 1 während eines zweiten Arbeitstaktes. Der zweite Arbeitstakt kann dem ersten Arbeitstakt entsprechend Fig. 1 nachfolgen. Fig. 4 shows the balancing device 100 of Fig. 1 during a second work cycle. The second work cycle can correspond to the first work cycle Fig. 1 follow.

Ein Strom 7c an Dialysierflüssigkeit wird im zweiten Arbeitstakt von einer Zentrifugalpumpe 15c durch den Schlauch 9c in die zweite Kammerhälfte 3b gefördert. Gleichzeitig wird ein Strom 7d an Dialysierflüssigkeit aus der ersten Kammerhälfte 3a entleert.A stream 7c of dialysis fluid is conveyed in the second power stroke by a centrifugal pump 15c through the hose 9c into the second chamber half 3b. At the same time, a stream 7d of dialysis fluid from the first chamber half 3a is emptied.

Fig. 5 zeigt die Bilanziereinrichtung 100 der Fig. 1 mit zwei zusätzlichen, der Bilanzierkammer 1 nachgeschalteten Zentrifugalpumpen 15b und 15d. Fig. 5 shows the balancing device 100 of Fig. 1 with two additional, the balancing chamber 1 downstream centrifugal pumps 15b and 15d.

Die in der erfindungsgemäßen Bilanziereinrichtung 100 der Fig. 5 angeordneten Zentrifugalpumpen 15a-d fördern alle in die gleiche Förderrichtung, wie mit den nach links (bezogen auf die Darstellung der Fig. 5) zeigenden Pumpenpfeilköpfen angedeutet ist.The in the inventive balancing device 100 of Fig. 5 arranged centrifugal pumps 15a-d promote all in the same conveying direction, as with the left (based on the representation of Fig. 5 ) pointing pump arrow heads is indicated.

Mit Hilfe der nachgeschalteten Zentrifugalpumpen 15b und 15d kann die Entleerung der beiden Kammerhälften 3a und 3b unterstützt werden. Dies kann vorteilhaft sein, um beispielsweise einen maximalen Druck (siehe in Fig. 2 den Endpunkt 18 der Kurve des Druckverlaufs) in der Bilanzierkammer 1 zu verringern oder niedrig zu halten. Niedrige Drücke in der Bilanzierkammer 1 können wiederum vorteilhaft dazu beitragen, die Konstruktion (wie z.B. eine geringere Steifigkeit, geringere Materialstärken etc.) der Bilanziereinrichtung 100 wie oben ausgeführt zu vereinfachen. Letzteres kann insbesondere bei einer Ausgestaltung der Bilanziereinrichtung 100 als Teil eines Disposables vorteilhaft sein.With the help of the downstream centrifugal pumps 15b and 15d, the emptying of the two chamber halves 3a and 3b can be supported. This may be advantageous, for example, to achieve maximum pressure (see Fig. 2 the end point 18 of the curve of the pressure curve) in the balancing chamber 1 to reduce or keep low. Low pressures in the balancing chamber 1 can in turn advantageously contribute to simplify the construction (such as a lower rigidity, lower material thicknesses, etc.) of the balancing device 100 as stated above. The latter can be advantageous in particular in one embodiment of the balancing device 100 as part of a disposable.

Fig. 6 zeigt die Bilanziereinrichtung 100 mit der Bilanzierkammer 1 ähnlich wie in Fig. 5, mit dem Unterschied, dass die Zentrifugalpumpe 15b vorgesehen und konfiguriert ist, auch in eine andere Richtung zu laufen bzw. in entgegengesetzte Richtungen zu fördern, wie mit dem nach links (bezogen auf die Darstellung der Fig. 6) zeigenden Pumpenpfeilkopf angedeutet ist. Fig. 6 shows the balancing device 100 with the balancing chamber 1 similar to in Fig. 5 with the difference that the centrifugal pump 15b is provided and configured to also run in a different direction or in opposite directions, as with the left (referring to the illustration of Fig. 6 ) pointing pump head is indicated.

Die Zentrifugalpumpe 15b arbeitet, wenn sie in entgegengesetzter Drehrichtung läuft, als Druckminderer, insbesondere als einstellbarer Druckminderer.The centrifugal pump 15b operates, when it runs in the opposite direction of rotation, as a pressure reducer, in particular as an adjustable pressure reducer.

In der Ausführungsform der Fig. 6 können Einlass und Auslass der Zentrifugalpumpe 15b vertauscht sein.In the embodiment of the Fig. 6 For example, the inlet and outlet of the centrifugal pump 15b may be reversed.

Ein "Vertauschen" von Einlass und Auslass kann auf verschiedene Weise erfolgen. Beispiele hierfür sind ein umgekehrtes Einbauen der Zentrifugalpumpe, ein Vorsehen von entsprechend angeordneten und angesteuerten Ventilen und dergleichen.An "exchange" of inlet and outlet can be done in various ways. Examples of this are a reverse installation of the centrifugal pump, a provision of appropriately arranged and controlled valves and the like.

Bei entsprechend angeordneten und angesteuerten Ventilen können diese bevorzugt durch Aktoren einer Dialysemaschine über eine flexible Membran betätigt werden, z.B. durch Abdrücken und/oder Freigeben der relevanten Fluidwege.With appropriately arranged and controlled valves, these can preferably be actuated by actuators of a dialysis machine via a flexible membrane, e.g. by impressing and / or releasing the relevant fluid paths.

Die Richtungsumkehr kann ergänzend oder alternativ vorgesehen sein. Die betrachtete Fördereinrichtung kann vorgesehen und konfiguriert sein, in einer oder in zwei, einander entgegengesetzten Richtungen betrieben zu werden.The direction reversal can be provided in addition or alternatively. The considered conveyor may be provided and configured to operate in one or two opposite directions.

Fig. 7 zeigt eine Zentrifugalpumpe 15a mit einem Laufrad 25 als Rotationsabschnitt, einem Rotor 27, Spulen 29 und einem Stator 31. Die Zentrifugalpumpe 15a weist ein Gehäuse 32 auf mit einem Zulass und einem Auslass (durch Pfeile in Fig. 7 als solche erkennbar). Fig. 7 shows a centrifugal pump 15a with an impeller 25 as a rotating section, a rotor 27, coils 29 and a stator 31. The centrifugal pump 15a has a housing 32 with an inlet and an outlet (indicated by arrows in FIG Fig. 7 recognizable as such).

Die Zentrifugalpumpe 15a wird in der gezeigten Strömungsrichtung durchströmt. Der Antrieb des Laufrades 25 erfolgt durch ein umlaufendes elektromagnetisches Feld, erzeugt mittels Ansteuern der Spulen 29 des Stators 31.The centrifugal pump 15a is flowed through in the flow direction shown. The drive of the impeller 25 is effected by a circulating electromagnetic field, generated by means of driving the coils 29 of the stator 31st

In das Laufrad 25 können Laufradmagnete oder wenigstens ferromagnetische Materialien integriert sein.In the impeller 25 impeller magnets or at least ferromagnetic materials may be integrated.

Die Lagerung des Laufrades 25 kann dann einerseits mittels der Laufradmagnete und andererseits mittels außerhalb der Zentrifugalpumpe vorgesehener Magnete erfolgen. Die Magnete können umlaufend in der gleichen Drehbewegung wie das Laufrad 25 angeordnet sein. Anstatt der umlaufenden Magnete oder ergänzend hierzu kann auch ein umlaufendes elektromagnetisches Feld in einer Spulenanordnung das Laufrad 25 lagern bzw. in einer stabilen umlaufenden Position fixieren. Diese Ausführungsform ist - obgleich nicht in den Figuren dargestellt - ebenfalls von der Erfindung umfasst.The bearing of the impeller 25 can then take place on the one hand by means of the impeller magnets and on the other hand by means provided outside of the centrifugal pump magnets. The magnets may be arranged circumferentially in the same rotational movement as the impeller 25. Instead of the rotating magnets or in addition thereto, a rotating electromagnetic field in a coil arrangement store the impeller 25 and fix it in a stable circumferential position. Although not shown in the figures, this embodiment is also included in the invention.

Fig. 8 zeigt schematisch vereinfacht eine erfindungsgemäße Bilanziereinrichtung 100 und eine erfindungsgemäße Behandlungsvorrichtung 300 mit einem Dialysator 33 mit einem Bluteinlass 33a und einem Blutauslass 33b, sowie weiteren Elementen. Fig. 8 schematically shows a simplified balancing device 100 according to the invention and a treatment device 300 according to the invention with a dialyzer 33 with a blood inlet 33a and a blood outlet 33b, and other elements.

Fig. 9 zeigt in Anlehnung an die Fig. 1 schematisch vereinfacht eine erfindungsgemäße Bilanziereinrichtung einer weiteren Ausführungsform während eines ersten Arbeitstaktes. Zu erkennen ist, dass die Zentrifugalpumpe 15b in entgegengesetzter Richtung zur Förderrichtung der Zentrifugalpumpe 15a fördert. Mittels dieser Ausführung der in entgegengesetzte Richtungen pumpenden Fördereinrichtungen kann einem ggf. zu hohen Eingangsdruck vorteilhaft entgegen gewirkt werden oder dieser gemindert werden. Dies kann der Fall sein, wenn das Dialysat aus einem RO-Wasser (reverse osmosis water) und Konzentraten hergestellt ist. Dabei kann der RO-Wasseranschluss einen derart hohen Leitungsdruck aufweisen, dass die Bilanziereinrichtung durch diesen beschädigt werden könnte. Fig. 9 shows in reference to the Fig. 1 schematically simplifies an inventive balancing a another embodiment during a first power stroke. It can be seen that the centrifugal pump 15b conveys in the opposite direction to the conveying direction of the centrifugal pump 15a. By means of this embodiment of the conveying devices pumping in opposite directions, an optionally too high inlet pressure can advantageously be counteracted or reduced. This may be the case when the dialysate is made from reverse osmosis water (RO) and concentrates. The RO water connection can have such a high line pressure that the balancing device could be damaged by it.

Claims (12)

  1. A balancing unit (100) for medical fluids comprising
    - at least one balancing chamber (1) and
    - at least one conveying means for filling the balancing chamber (1),
    wherein the conveying means is a pressure limited conveying means,
    characterized in that the conveying means is a centrifugal pump which, due to its type, does not build up a pressure above a predetermined pressure, without being supported by further elements.
  2. The balancing unit (100) according to claim 1, wherein the conveying means comprises at least one rotational section provided and designed for being actuated magnetically by means of an external actuator or by means of an electrical field.
  3. The balancing unit (100) according to claim 2, wherein the external actuator is not part of the balancing unit.
  4. The balancing unit (100) according to anyone of the preceding claims, wherein the medical fluid is selected from blood, dialysis liquid, substituate liquid, drugs, drug preparations as well as mixtures or combinations thereof.
  5. The balancing unit (100) according to anyone of the preceding claims, wherein the conveying means comprises at least one first conveying means provided to convey in a first direction and at least one second conveying means provided to convey in a second direction opposite to the first direction.
  6. The balancing unit (100) according to anyone of the preceding claims, wherein the conveying means comprises at least one first conveying means provided to convey in a first direction and at least one second conveying means provided to convey in the first direction, too.
  7. An external medical functional means (200) comprising at least one balancing unit (100) according to anyone of claims 1 to 6.
  8. The external medical functional means (200) according to claim 7, configured as an external or extracorporeal blood circuit or blood cassette.
  9. The external medical functional means (200) according to claim 7 or 8, configured as a disposable or one-way article for insertion in a blood treatment apparatus, wherein the functional means (200) comprises at least one pressure limited conveying means and at least one integrated balancing chamber which is separated into two chamber sections by means of one or at least one flexible membrane.
  10. A treatment apparatus (300) for treating medical fluids comprising at least one balancing unit (100) according to anyone of claims 1 to 6.
  11. The treatment apparatus (300) according to claim 10, functionally connected with a balancing unit (100) according to anyone of claims 1 to 6 and/or with an external medical functional means (200) according to claims 7 to 9.
  12. The treatment apparatus (300) according to anyone of claims 10 to 11, configured as a blood treatment apparatus, in particular as a hemodialysis machine.
EP20100803227 2009-12-16 2010-12-15 Balancing device, external medical functional device, treatment device Active EP2512547B1 (en)

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DE102009058681A DE102009058681A1 (en) 2009-12-16 2009-12-16 Balancing device, external medical functional device, treatment device and method
PCT/EP2010/007647 WO2011082783A1 (en) 2009-12-16 2010-12-15 Balancing device, external medical functional device, treatment device, and methods

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JP (1) JP5889204B2 (en)
KR (1) KR101801175B1 (en)
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IN2012DN05224A (en) 2015-10-23
CA2784205C (en) 2018-09-04
BR112012014165B1 (en) 2020-09-29
EA026790B1 (en) 2017-05-31
JP5889204B2 (en) 2016-03-22
US9919090B2 (en) 2018-03-20
AU2010341195A1 (en) 2012-07-05
EP2512547A1 (en) 2012-10-24
AU2010341195B2 (en) 2015-02-26
ES2543901T3 (en) 2015-08-25
JP2013514095A (en) 2013-04-25
PL2512547T3 (en) 2015-10-30
WO2011082783A1 (en) 2011-07-14
US20120267309A1 (en) 2012-10-25
CA2784205A1 (en) 2011-07-14
CN102655894A (en) 2012-09-05
CN102655894B (en) 2016-03-02
DE102009058681A1 (en) 2011-06-22
DE102009058681A9 (en) 2012-04-19
KR101801175B1 (en) 2017-11-24
EA201200897A1 (en) 2013-01-30
KR20120120167A (en) 2012-11-01
BR112012014165A2 (en) 2016-05-17

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